Panels › Gastroenterology, Urology › Product code MSD · Class 2
Catheter, Hemodialysis, Implanted
Regulation 876.5540
0510(k)s in 12 months (124 all time)
8recalls in 12 months (270 all time)
257recalls that name a 510(k)
Top companies in MSD
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien | 3 | 71 |
| Spire Biomedical, Inc. | 13 | 48 |
| Arrow International, Inc. | 4 | 50 |
| AngioDynamics, Inc. | 4 | 34 |
| Bard Peripheral Vascular, Inc. | 1 | 30 |
| Angiodynamics Worldwide Headquarters | 0 | 16 |
| Medcomp | 13 | 0 |
| C. R. Bard | 12 | 0 |
| Kendall | 9 | 0 |
| Marvao Medical Devices, Ltd. | 7 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 16, 2025 | K241581 | Hemodialysis Catheter Haolang Medical USA Corporation | MSD |
| Sep 14, 2021 | K210461 | End Cap Medical Components Inc (Medcomp) | MSD |
| Jul 1, 2021 | K203575 | GlidePath Retro Long-Term Hemodialysis Catheter C.R. Bard, Inc. | MSD |
| Jun 4, 2021 | K211410 | GlidePath 13F Long-Term Hemodialysis Catheter Bard Peripheral Vascular, Inc. | MSD |
| Apr 2, 2021 | K203767 | Pristine Long-Term Hemodialysis Catheter C B Bard, Inc. | MSD |
| Nov 18, 2020 | K202150 | GlidePath 7.5F Long-Term Dialysis Catheter C.R. Bard, Inc. | MSD |
| Sep 3, 2020 | K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes Medical Components, Inc. (dba MedComp) | MSD |
| Jun 22, 2020 | K200627 | GlidePath 10F Long-Term Dialysis Catheter C.R. Bard, Inc. | MSD |
| Mar 5, 2020 | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysi C. R. Bard | MSD |
| May 31, 2019 | K182443 | Pristine Hemodialysis Catheter Pristine Access Technologies , Ltd., IL | MSD |
| May 17, 2018 | K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Cat Medical Components, Inc. (dba MedComp) | MSD |
| Feb 8, 2018 | K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter Marvao Medical Devices, Ltd., IE | MSD |
| Nov 30, 2017 | K171571 | NexSite HD, Hemodialysis Step Tip Catheter (60cm) Marvao Medical Devices, Ltd., IE | MSD |
| Nov 16, 2017 | K171618 | Symetrex Long Term Hemodialysis Catheter Medcomp (Dba Medical Components, Inc.) | MSD |
| Aug 9, 2016 | K161026 | NexSite 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., IE | MSD |
| Apr 4, 2016 | K151967 | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter Merit Medical Systems, Inc. | MSD |
| Mar 31, 2015 | K143567 | NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long Marvao Medical Devices, Ltd., IE | MSD |
| Nov 26, 2014 | K140884 | SYMETREX LONG TERM HEMODIALYSIS CATHETER Phase One Medical | MSD |
| Nov 13, 2014 | K140492 | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE Marvao Medical Devices, Ltd. | MSD |
| Jul 7, 2014 | K141051 | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU Arrow International, Inc. | MSD |
| Jun 18, 2014 | K141363 | CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER Merit Medical Systems, Inc. | MSD |
| Apr 28, 2014 | K130889 | SPLIT CATH RG Medcomp | MSD |
| Feb 14, 2014 | K131260 | NMI DIALYSIS CATHETER Navilyst Medical, Inc. | MSD |
| Jan 31, 2014 | K133796 | NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), Marvao Medical Devices, Ltd. | MSD |
| Jan 9, 2014 | K130851 | CASCADE HEMODIALYSIS/APHERESIS CATHETER Health Line International Corporation | MSD |
| Jul 26, 2013 | K131814 | AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER Ameco Medical Industries | MSD |
| May 10, 2013 | K130192 | NEXTSTEP RETROGRADE Arrow International, Inc. | MSD |
| Apr 2, 2013 | K123943 | AMECATH DUAL LUMEN HEMODIALYSIS CATHETER Ameco Medical Industries | MSD |
| Mar 14, 2013 | K121933 | NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) Marvao Medical Devices, Ltd. | MSD |
| Jan 31, 2013 | K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH Covidien | MSD |
| Sep 21, 2012 | K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM Medical Components, Inc. | MSD |
| Mar 9, 2012 | K113487 | HEMO-CATH 10F, HEMO-CATH 12.5F Medical Components, Inc. | MSD |
| Dec 8, 2011 | K111651 | SPLIT CATH III Medical Components, Inc. | MSD |
| Aug 30, 2011 | K111817 | PALINDROME RT CHRONIC CATHETER Covidien | MSD |
| Aug 17, 2011 | K111900 | NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflexmedical, Inc. | MSD |
| Aug 4, 2011 | K111372 | TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... Covidien | MSD |
| Jun 30, 2011 | K111117 | CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... Teleflexmedical, Inc. | MSD |
| Jun 10, 2011 | K110936 | DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. | MSD |
| Feb 1, 2011 | K102238 | ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflexmedical, Inc. | MSD |
| Nov 18, 2010 | K102043 | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER Rex Medical | MSD |
| Oct 20, 2010 | K101843 | DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. | MSD |
| Feb 18, 2010 | K100169 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER R4 Vascular, Inc. | MSD |
| Jan 8, 2010 | K091506 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 R4 Vascular, Inc. | MSD |
| Nov 12, 2009 | K092597 | CENTROS CHRONIC HEMODIALYSIS CATHETER SET Ash Access Technology, Inc. | MSD |
| Oct 30, 2009 | K092205 | PALINDROME P HEMODIALYSIS CATHETER Covidien Lp, Formerly Registered AS Kendall | MSD |
| Jul 20, 2009 | K091760 | DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) Dermaport, Inc. | MSD |
| May 28, 2009 | K090528 | DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT C.R. Bard, Inc. | MSD |
| Apr 13, 2009 | K090148 | PROGUIDE CHRONIC DIALYSIS CATHETER Merit Medical Systems, Inc. | MSD |
| Feb 10, 2009 | K090101 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS C.R. Bard, Inc. | MSD |
| May 13, 2008 | K080400 | ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc. | MSD |
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