510(k) · Cleared
Recalled · Class I · 2023CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Feb 4, 2016 as substantially equivalent to K141618 (Arrow International, Inc (Subsidiary of Teleflex I, 2014) after a 62-day review. Its family tree reaches back 13 generations to 2000. 6 of the 62 devices in its family, counting itself, have a Class I recall. It has been recalled 8 times, including a Class I recall.
- Decided
- Feb 4, 2016
- Review
- 62 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 8 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 13 generations to K001901 (2000). 61 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet. 6 of the 62 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
- 2 generations backK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · Recalled (Class I)
- 1 generation backK141618 Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet…Arrow International, Inc (Subsidiary of Teleflex I · 2014
- This deviceK153487 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016
Show all 13 generations
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 12 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 11 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 10 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 9 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 8 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 7 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 6 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 5 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 4 generations backK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- 3 generations backK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
- 2 generations backK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · Recalled (Class I)
- 1 generation backK141618 Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet…Arrow International, Inc (Subsidiary of Teleflex I · 2014
- This deviceK153487 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −12 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −11 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −10 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −9 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −8 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −7 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −6 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −5 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −4 | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | 4 |
| −3 | K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. (Subsidiary of Teleflex | 2013 | — |
| −2 | K130876 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. | 2013 | Class I |
| −1 | K141618 | Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus | Arrow International, Inc (Subsidiary of Teleflex I | 2014 | — |
| 0 (this device) | K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 1 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 1 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 2 |
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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K141618 | Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusSummary page 6…fication Regulation: Catheter: 21 CFR: 880.5970 FDA Classification (Catheter and Stylet): Class II FDA Product Code: Catheter: LJS Stylet: OBJ Predicate Devices • K141618: Arrow Vascular Positioning System (VPS) stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS Modifications… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class I | Z-0001-2024 | 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. |
| Apr 23, 2019 | Class II | Z-1808-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1807-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1810-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Dec 13, 2018 | Class II | Z-1366-2019 | Employee error | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC |
| Dec 13, 2018 | Class II | Z-1365-2019 | Employee error | Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC |
| Jul 17, 2018 | Class II | Z-3200-2018 | Under Investigation by firm | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen… |
| Jul 17, 2018 | Class II | Z-3199-2018 | Under Investigation by firm | The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen… |
The 5 latest of 8 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.
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 8 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 9 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 22 of the 61 ancestors have a recall of any class; 5 have a Class I recall.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injection equipment used with the pressure injectable PICC may not exceed 300 psi. Chlorag+ard Technology…
Read the full statement (578 words)
The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injection equipment used with the pressure injectable PICC may not exceed 300 psi.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient’s physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.
The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient’s physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.
The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153487: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153487
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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