510(k) · Cleared
Recalled · Class I · 2026Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 30, 2007 as substantially equivalent to K862056 (Arrow Intl., Inc., 1986) and 5 other predicates after an 86-day review. Its family tree reaches back 8 generations to 2000. 6 of the 38 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 54 times, including 5 Class I recalls.
- Decided
- Aug 30, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 54 (5 Class I)
- Predicates
- 6
Its longest line of descent runs back 8 generations to K001901 (2000). 23 ancestors in all, the oldest K830256 (1983). 14 later devices descend from it, 5 citing it directly. 6 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 1 generation backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- This deviceK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
- Descendant · cites it directly · 3 of its ownK190855 BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019
- Descendant · 2 generations on · 3 of its ownK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK091709 Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009
- Descendant · cites it directly · 1 of its ownK160645 PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…direct predicate · 2000
- K900263 Antimicrobial Multi-Lumen Central Venous Catheterdirect predicate · 1990
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tipdirect predicate · 1986
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet2 generations on · 2013
Most influential descendants
Showing 5 of 14 · See all- K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012 · cites it directly4descendants
- K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019 · cites it directly3descendants
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 2 generations on3descendants
- K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009 · cites it directly2descendants
- K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −3 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −1 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| 0 (this device) | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous… | Arrow International, Inc. | 2007 | — |
| +1 | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
| +1 | K190855 | BD Acute Central Line | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2019 | — |
| +2 | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | Class I |
| +1 | K091709 | Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC | Edwards Lifesciences, LLC | 2009 | — |
| +1 | K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1989 | 1 | 0 |
| 1990 | 1 | 1 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 4 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862056 | [Central Venous][Multi-Lumen] Catheter W/Flex TipSummary page 1…21 CFR 880.5200, Class 11 Legally marketed devices to Arrow Standard Multiple Lumen CVC with Blue FlexTip® which the device is (K862056, SE date 8/25/1986) substantially equivalent: ARROWg+ard Blue® CVC (K900263, SE date… | 1986 |
| * | K900263 | Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…Blue FlexTip® which the device is (K862056, SE date 8/25/1986) substantially equivalent: ARROWg+ard Blue® CVC (K900263, SE date 7/24/1 990 and K962577, SE date 8/27/1997) ARROWg+… | 1990 |
| * | K962577 | Arrowgard Blue Quad-Lumen Central Venous CatheterSummary page 1…is (K862056, SE date 8/25/1986) substantially equivalent: ARROWg+ard Blue® CVC (K900263, SE date 7/24/1 990 and K962577, SE date 8/27/1997) ARROWg+ard Blue PLUS® CVC… | 1997 |
| * | K993691 | Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…1 990 and K962577, SE date 8/27/1997) ARROWg+ard Blue PLUS® CVC (K993691, SE date 3/8/2000) Bard Access System, Inc PowerHickman (K0… | 2000 |
| * | K061179 | Powerhickman Long-Term Intravascular CatheterSummary page 1…(K993691, SE date 3/8/2000) Bard Access System, Inc PowerHickman (K061 179, SE date 8/9/2006) Arrow Berman Angiographic Catheter devices… | 2006 |
| * | K892530 | Catheters for Balloon Occlusion Femoral AngiographSummary page 1…(K061 179, SE date 8/9/2006) Arrow Berman Angiographic Catheter devices (K892530, SE date 9/26/1 989) Description of the device: The Arrow CVC have the following characteristics:… | 1989 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | 2012 | 4 |
| K190855 | BD Acute Central Line | 2019 | 3 |
| K091709 | Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC | 2009 | 2 |
| K160645 | PreSep Oligon Oximetry Catheter | 2016 | 1 |
| K150109 | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain… | 2015 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2376-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Mar 11, 2026 | Class II | Z-1914-2026 | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| Jan 7, 2026 | Class II | Z-2123-2026 | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues… |
| Aug 10, 2023 | Class I | Z-0003-2024 | Under Investigation by firm | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| Aug 10, 2023 | Class I | Z-0002-2024 | Under Investigation by firm | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| Oct 27, 2022 | Class I | Z-0352-2023 | Process design | There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus… |
| Oct 27, 2022 | Class I | Z-0351-2023 | Process design | There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus… |
| May 25, 2022 | Class II | Z-1604-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
| Apr 11, 2018 | Class II | Z-1993-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1988-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1987-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1980-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1994-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1998-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1990-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1997-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2000-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1991-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1996-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1979-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1992-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1989-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1995-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1981-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1999-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1326-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
| Nov 27, 2017 | Class II | Z-1005-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 27, 2017 | Class II | Z-1004-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 27, 2017 | Class II | Z-0994-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 27, 2017 | Class II | Z-1003-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 27, 2017 | Class II | Z-0995-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 27, 2017 | Class II | Z-0997-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 27, 2017 | Class II | Z-0998-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 27, 2017 | Class II | Z-0999-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| Nov 14, 2017 | Class II | Z-1159-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Nov 14, 2017 | Class II | Z-1162-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Nov 14, 2017 | Class II | Z-1166-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Nov 14, 2017 | Class II | Z-1164-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Nov 14, 2017 | Class II | Z-1163-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Nov 14, 2017 | Class II | Z-1161-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Nov 14, 2017 | Class II | Z-1165-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Oct 17, 2017 | Class II | Z-0653-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0655-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0647-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0649-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0651-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| May 9, 2017 | Class II | Z-2330-2017 | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. |
| Mar 17, 2017 | Class II | Z-1879-2017 | Process control | Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover. |
| Jun 2, 2016 | Class II | Z-2136-2016 | Process control | Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit. |
| Jan 2, 2015 | Class II | Z-1082-2015 | Process control | Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user. |
The 5 latest of 50 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Direct predicate · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Direct predicate · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 12 of the 23 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K121501 (Arrow International (Subsidiary of Teleflex Inc.), 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K862056.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The ARROWg+ard Blue® antimicrobial catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: * Lack of usable peripheral IVsites * Central venous pressure monitoring * Total parenteral nutrition (TPN) * Infusions of fluids, medications, or chemotherapy * Frequent blood sampling or receiving blood transfusions/blood…
Read the full statement (379 words)
The ARROWg+ard Blue® antimicrobial catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:
* Lack of usable peripheral IVsites
* Central venous pressure monitoring
* Total parenteral nutrition (TPN)
* Infusions of fluids, medications, or chemotherapy
* Frequent blood sampling or receiving blood transfusions/blood products
* Injection of contrast media
When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.
The ARROWg+ard Blue PLUS® antimicrobial multiple-lumen catheter is indicated to permit shodt-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:
* Replacement of multiple peripheral sites for IV access
* Lack of usable peripheral IV sites
* Central venous pressure monitoring
* Total parenteral nutrition (TPN)
* Infusion of incompatible medications
* Multiple infusions of fluids, medications, or chemotherapy
* Frequent blood sampling or receiving blood transfusions/blood products
* Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
* Injection of contrast media
When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.
The Arrow catheter is indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including. but not limited to the following:
* Replacement of multiple peripheral sites for IV access
* Lack of usable peripheral IV sites
* Central venous pressure monitoring
* Total parenteral nutrition (TPN)
* Infusion of incompatible medications
* Multiple infusions of fluids, medications, or chemotherapy
* Frequent blood sampling or receiving blood transfusions/blood products
* Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
* Injection of contrast media
When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071538 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071538
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026