510(k) Report

510(k) · Cleared

Cleared

Nexsite 9FR Dual Lumen Critical Care Central Venous Catheter

K110627510(k) TraditionalCleared Aug 12, 2011161-day reviewClass II21 CFR 880.5970

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

Marvao Medical Devices, Ltd. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Aug 12, 2011 as substantially equivalent to K061179 (C.R. Bard, Inc., 2006) and 1 other predicate after a 161-day review. Its family tree reaches back 8 generations to 2000. 2 of the 27 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.

Decided
Aug 12, 2011
Review
161 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K001901 (2000). 21 ancestors in all, the oldest K830256 (1983). 5 later devices descend from it, 1 citing it directly. 2 of the 27 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestor2003: 1 other ancestor1983: 1 other ancestor2001: 2 other ancestors2000: 2 other ancestors, 1 with a Class I recall11999: 1 other ancestor1996: 1 other ancestor1986: 1 other ancestor, 1 with a Class I recall12013: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant clearedK001901 · 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. · 2003K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalled×3: 3 generations cleared close together, K050185 (2005), K051417 (2005), K051991 (2005) K061179 · Powerhickman Long-Term Intravascular Catheter · C.R. Bard, Inc. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 5 other ancestors4 generations back: 6 other ancestors, 1 with a Class I recall15 generations back: 1 other ancestor, 1 with a Class I recall1 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant K061179 · Powerhickman Long-Term Intravascular Catheter · C.R. Bard, Inc. · 2006K051991 · Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line · C.R. Bard, Inc. · 2005K051417 · 6 FR FL Powerhohn and Powerline Catheter · C.R. Bard, Inc. · 2005 · recalledK050185 · Powerhohn and Powerline Catheters · C.R. Bard, Inc. · 2005K033389 · Powerpicc Catheters, Models 3175155, 3175135 · 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−50
  1. Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. 1 generation backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
  9. This deviceK110627 Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd. · 2011
  10. Descendant · cites it directly · 4 of its ownK121933 Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD…Marvao Medical Devices, Ltd. · 2013
  11. Descendant · 2 generations on · 3 of its ownK133796 Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite…Marvao Medical Devices, Ltd. · 2014
  12. Descendant · 2 generations on · 2 of its ownK140492 Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd. · 2014
  13. Descendant · 2 generations on · 1 of its ownK161026 NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm…Marvao Medical Devices, Ltd. · 2016
  14. Descendant · 3 generations on · 0 of its ownK173805 NexSite HD Hemodialysis Symmetric Tip Catheter for long term use…Marvao Medical Devices, Ltd. · 2018 · Recalled

Class I recalls in this family

  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…4 generations back · 2000
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip5 generations back · 1986

Most influential descendants

Showing 5 of 5 · See all
  • K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd. · 2013 · cites it directly4descendants
  • K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd. · 2014 · 2 generations on3descendants
  • K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd. · 2014 · 2 generations on2descendants
  • K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd. · 2016 · 2 generations on1descendant
  • K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−7K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−6K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−5K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−4K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−3K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−2K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
−1K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.2006—
0 (this device)K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.2011—
+1K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD…Marvao Medical Devices, Ltd.2013—
+2K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD…Marvao Medical Devices, Ltd.2014—
+2K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.2014—
+2K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32…Marvao Medical Devices, Ltd.2016—
+3K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm)…Marvao Medical Devices, Ltd.20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
199610
199910
200021
200120
200310
200410
200520
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201610
201810
FIG. 1 — Lineage of K110627, 2000–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

2 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. #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 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? (2)

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
*K061179Powerhickman Long-Term Intravascular Catheter
Summary page 1
…a. The maximum pressure of power injectors used with the NexSite device may not exceed 300psi. Predicate Devices PowerHickman®D Central Venous Catheter K061 179 Manufactured by Bard Access Systems Medcomp®)PRO-LINETM CT Power Injectable CVC K053345 Manufactured by…
C.R. Bard, Inc.2006—
*K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D
Summary page 1
…vices PowerHickman®D Central Venous Catheter K061 179 Manufactured by Bard Access Systems Medcomp®)PRO-LINETM CT Power Injectable CVC K053345 Manufactured by Medcomp® Device Description The NexSite 9Fr Dual Lumen Catheter is a long-term central venous catheter. Th…
Medcomp20061

Also cleared against K061179: 2 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134

Has anything in its family been recalled? (2 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.

  • K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 4 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 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 10 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K121933 (Marvao Medical Devices, Ltd., 2013) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K061179.

How does its category compare?

All LJS devices

LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LJS

8in 2025

2007: 142008: 42009: 162010: 92011: 62012: 142013: 142014: 82015: 72016: 92017: 72018: 102020: 22021: 32022: 32023: 42024: 12025: 82026 (partial year): 2
2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007: 92 days median2008: 97 days median2009: 70 days median2010: 114 days median2011: 55 days median2012: 77 days median2013: 31 days median2014: 47 days median2015: 71 days median2016: 128 days median2017: 101 days median2018: 148 days median2021: 284 days median2022: 177 days median2023: 47 days median2025: 171 days median
2007high 284 (2021) · low 31 (2013)2026

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

Recalls per year · LJS

5in 2023

2008: 12009: 12010: 122011: 42012: 402014: 152015: 22016: 182017: 92018: 32021: 12023: 5, 2 Class I2026 (partial year): 8, 1 Class I
2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007: 3922008: 3692009: 3792010: 4952011: 6962012: 5642013: 6802014: 8422015: 1,3062016: 1,1232017: 2,1002018: 2,3242019: 2,0522020: 2,5392021: 3,0842022: 3,2562023: 2,7992024: 4,2432025: 4,372
2007high 4,372 (2025) · low 369 (2008)2025

MAUDE reports naming product code LJS, 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
200714920392
20084971369
200916701379
2010911412495
20116554696
2012147740564
201314310680
201484715842
201577121,306
20169128181,123
2017710192,100
20181014832,324
20190—02,052
20202—02,539
2021328413,084
2022317703,256
20234475 (2)2,799
20241—04,243
2025817104,372
20262—8 (1)—

What is it indicated for?

The NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter is indicated for long-term access to the Central Venous System. It is designed for administering IV fluids, blood products, drugs, and parenteral nutrition as well as blood withdrawal and power injection of contrast media. The maximum pressure of power injectors used with the NexSite device may not exceed 300 psi.

Indications for use as stated in the FDA summary.

Also cleared against K061179

2 other devices cite the same predicate.

  • K101326NMI ICNavilyst Medical, Inc. · 2010
  • K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 20075 Class I recalls

More from Marvao Medical Devices, Ltd.

9 FDA decisions under this applicant name. See the company

  • K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd. · 2022
  • K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric…Marvao Medical Devices, Ltd. · 20181 recall
  • K171571NexSite HD, Hemodialysis Step Tip Catheter (60cm)Marvao Medical Devices, Ltd. · 2017
  • K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)Marvao Medical Devices, Ltd. · 2016
  • K143567NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip…Marvao Medical Devices, Ltd. · 2015

Recent decisions in LJS

The LJS category page

  • K260080Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerMedical Components, Inc. · 2026
  • K260929Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
  • K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and…Spectrum Vascular · 2025
  • K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
  • K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single…Access Vascular, Inc. · 2025

https://510kreport.com/device/K110627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110627: Nexsite 9FR Dual Lumen Critical Care Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110627

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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