510(k) Report

510(k) · Cleared

Cleared

Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus

K141618510(k) SpecialCleared Jul 8, 201421-day reviewClass II21 CFR 870.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arrow International, Inc (Subsidiary of Teleflex I · OBJ Catheter, Ultrasound, Intravascular

Cleared on Jul 8, 2014 as substantially equivalent to K103255 (Vasonova, Inc., 2011) and 3 other predicates after a 21-day review. Its family tree reaches back 12 generations to 2000. 6 of the 62 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided
Jul 8, 2014
Review
21 days
Class
Class II
Product code
OBJ
Recalls
None
Predicates
4

Its longest line of descent runs back 12 generations to K001901 (2000). 60 ancestors in all, the oldest K823434 (1982). 1 later device descends from it, 1 citing it directly. 6 of the 62 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2012: 2 other ancestors, 2 with a Class I recall22010: 1 other ancestor2009: 1 other ancestor2004: 3 other ancestors2003: 2 other ancestors1984: 1 other ancestor2008: 3 other ancestors2006: 3 other ancestors2002: 2 other ancestors1997: 1 other ancestor1992: 2 other ancestors2005: 6 other ancestors2000: 3 other ancestors, 1 with a Class I recall11996: 3 other ancestors1995: 2 other ancestors1994: 3 other ancestors1993: 1 other ancestor1991: 2 other ancestors1986: 2 other ancestors, 1 with a Class I recall11982: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1983: 1 other ancestor2016: 1 descendant cleared, 1 with a Class I recall1K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK060341 · Sherlock Tip Location System (TLS) · C.R. Bard, Inc. · 2006K063240 · Sherlock TLS Stylet, Sherlock TLS Detector · C.R. Bard, Inc. · 2006 · recalledK081625 · Flowpicc Stylet · Vasonova, Inc. · 2008K091324 · Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet · C.R. Bard, Inc. · 2009 · recalledK093775 · Evguide Tip Location System · Romedex International Srl · 2010K103255 · Vascular Positioning System TM (VPS TM System) Stylet · Vasonova, Inc. · 2011 · recalled×2: 2 generations cleared close together, K123759 (2013), K130876 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor, 1 with a Class I recall12 generations back: 1 other ancestor, 1 with a Class I recall13 generations back: 5 other ancestors4 generations back: 7 other ancestors5 generations back: 17 other ancestors6 generations back: 9 other ancestors7 generations back: 7 other ancestors, 1 with a Class I recall18 generations back: 1 other ancestor, 1 with a Class I recall1 1 generation forward: 1 descendant, 1 with a Class I recall1 K130876 · CG+ Arrow Picc Powered by Arrow VPS Stylet · Arrow International, Inc. · 2013 · Class I recallK123759 · CG+ Arrow Picc Powered by Arrow VPS Stylet · Arrow International, Inc. (Subsidiary of Teleflex · 2013K103255 · Vascular Positioning System TM (VPS TM System) Stylet · Vasonova, Inc. · 2011 · recalledK093775 · Evguide Tip Location System · Romedex International Srl · 2010K091324 · Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet · C.R. Bard, Inc. · 2009 · recalledK081625 · Flowpicc Stylet · Vasonova, Inc. · 2008K063240 · Sherlock TLS Stylet, Sherlock TLS Detector · C.R. Bard, Inc. · 2006 · recalledK060341 · Sherlock Tip Location System (TLS) · C.R. Bard, Inc. · 2006K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−10−50
  1. Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 8 generations between
  3. 3 generations backK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
  4. 2 generations backK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
  5. 1 generation backK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · Recalled (Class I)
  6. This deviceK141618 Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet…Arrow International, Inc (Subsidiary of Teleflex I · 2014
  7. Descendant · cites it directly · 0 of its ownK153487 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
Show all 12 generations
  1. Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 11 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 10 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 9 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 8 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
  6. 7 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
  7. 6 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
  8. 5 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
  9. 4 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
  10. 3 generations backK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
  11. 2 generations backK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
  12. 1 generation backK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · Recalled (Class I)
  13. This deviceK141618 Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet…Arrow International, Inc (Subsidiary of Teleflex I · 2014

Class I recalls in this family

Most influential descendants

Showing 1 of 1 · See all
  • K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−11K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−10K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−9K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−8K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc.2006—
−7K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc.200618
−6K081625Flowpicc StyletVasonova, Inc.2008—
−5K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.200911
−4K093775Evguide Tip Location SystemRomedex International Srl2010—
−3K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc.20114
−2K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex2013—
−1K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.2013Class I
0 (this device)K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I2014—
+1K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)2016Class I

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198310
198410
198621
199120
199220
199310
199430
199520
199630
199710
199910
200031
200120
200220
200320
200430
200560
200630
200830
200910
201010
201222

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201611
FIG. 1 — Lineage of K141618, 2000–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OBJ device

  1. #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K103255Vascular Positioning System TM (VPS TM System) Stylet
Summary page 1
…Common Name, Stylet: Catheter, Ultrasound, Intravascular Classification Name, Stylet: Diagnostic Intravascular Catheter per 21 CER 870.1200 Predicate Devices * K 103255: Vascular Positioning System (VPS) Stylei * K 122545: 4.5 French CG& Arrow P1CC powered by Arrow VPS Stylet * K 123'7…
Vasonova, Inc.20114
*K122545CG+ Arrow Picc Powered by Arrow VPS Stylet
Summary page 1
…lassification Name, Stylet: Diagnostic Intravascular Catheter per 21 CER 870.1200 Predicate Devices * K 103255: Vascular Positioning System (VPS) Stylei * K 122545: 4.5 French CG& Arrow P1CC powered by Arrow VPS Stylet * K 123'759: 5.5 French CG+ Arrow P1CC powered by Arrow VPS Stylet…
Arrow International (Subsidiary of Teleflex Inc.)2012Class I
*K123759CG+ Arrow Picc Powered by Arrow VPS Stylet
Summary page 4
…ow P1CC powered by Arrow VPS Stylet PLUS is substantially equivalent to the predicate VPS Stylet (K 103255) and the CG± Arrow P1CC powered by Arrow VPS Stylet (K 122545, K 123759, K130876) in terms of intended use, indications for use, patient population, contraindications, operating principle, functional p…
Arrow International, Inc. (Subsidiary of Teleflex2013—
*K130876CG+ Arrow Picc Powered by Arrow VPS Stylet
Summary page 1
…tem (VPS) Stylei * K 122545: 4.5 French CG& Arrow P1CC powered by Arrow VPS Stylet * K 123'759: 5.5 French CG+ Arrow P1CC powered by Arrow VPS Stylet * K 130876: 6 French CG+ Arrow P1CC powered by Arrow VPS Stylet Device Description The Arrow Vascular Positioning System (VPS) Stylet PLU…
Arrow International, Inc.2013Class I

Also cleared against K103255: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS Class IArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

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 · Direct predicate · ◆ 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 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
  • K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 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 · 7 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 · 8 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
  • K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 12 months on median.
  • 22 of the 60 ancestors have a recall of any class; 5 have a Class I recall.
  • Of its descendants, K153487 (Arrow International, Inc. (Subsidiary of Teleflex, Inc.), 2016) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K103255.

How does its category compare?

All OBJ devices

OBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · OBJ

7in 2025

2007: 32008: 62009: 32010: 12011: 42012: 32013: 42014: 32015: 42016: 42017: 62018: 22019: 12020: 42021: 32022: 32023: 32024: 32025: 72026 (partial year): 4
2007high 7 (2025) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBJ

35in 2025

2007: 74 days median2008: 100 days median2009: 108 days median2011: 109 days median2012: 136 days median2013: 96 days median2014: 30 days median2015: 131 days median2016: 94 days median2017: 45 days median2020: 135 days median2021: 29 days median2022: 63 days median2023: 63 days median2024: 131 days median2025: 35 days median2026 (partial year): 81 days median
2007high 136 (2012) · low 29 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OBJ

2in 2020

2015: 22017: 22018: 22020: 22026 (partial year): 1, 1 Class I
2007high 2 (2015) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OBJ

791in 2025

2008: 62009: 222010: 392011: 472012: 532013: 3282014: 6092015: 4012016: 5152017: 5242018: 5422019: 2372020: 2882021: 3532022: 4732023: 6972024: 1,1542025: 791
2007high 1,154 (2024) · low 0 (2007)2025

MAUDE reports naming product code OBJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200737400
2008610006
20093108022
20101—039
20114109047
20123136053
20134960328
20143300609
201541312401
20164940515
20176452524
20182—2542
20191—0237
202041352288
20213290353
20223630473
20233630697
2024313101,154
20257350791
20264811 (1)—

What is it indicated for?

The VI'S Stylet and Console an indicated ror guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement or the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VI'S Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical…

Read the full statement (575 words)

The VI'S Stylet and Console an indicated ror guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement or the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VI'S 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 VI'S 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, stadard 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 atriall fibrillation, trial 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 I'-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 Pressur Injectable P1CC 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 ofpressure injection equipment used with the pressure injectable P1CC catheter 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 effecive in reducing microbial colonization and thronmbus 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 ECO detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-ime catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VI'S System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VI'S System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venious catheter tip placement confinnation in adult patients when asteady Blue Bullseye is obtained. NOTE: If asteady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contrindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atria] 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 theP-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 as stated in the FDA summary.

Cite this page

510(k) Report. “K141618: Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141618

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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