MSD · Class II · 21 CFR 876.5540

FDA Product Code MSD: Catheter, Hemodialysis, Implanted

Leading manufacturers include Medcomp, Spire Biomedical, Inc. and C.R. Bard, Inc..

124
Total
124
Cleared
139d
Avg days
1998
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 347d recently vs 137d historically

FDA 510(k) Cleared Catheter, Hemodialysis, Implanted Devices (Product Code MSD)

124 devices
1–24 of 124
Cleared May 16, 2025
Hemodialysis Catheter
K241581
Haolang Medical USA Corporation
Gastroenterology & Urology · 347d
Cleared Sep 14, 2021
End Cap
K210461
Medical Components Inc (Medcomp)
Gastroenterology & Urology · 210d
Cleared Jul 01, 2021
GlidePath Retro Long-Term Hemodialysis Catheter
K203575
C.R. Bard, Inc.
Gastroenterology & Urology · 206d
Cleared Jun 04, 2021
GlidePath 13F Long-Term Hemodialysis Catheter
K211410
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 02, 2021
Pristine Long-Term Hemodialysis Catheter
K203767
C B Bard, Inc.
Gastroenterology & Urology · 100d
Cleared Nov 18, 2020
GlidePath 7.5F Long-Term Dialysis Catheter
K202150
C.R. Bard, Inc.
Gastroenterology & Urology · 107d
Cleared Sep 03, 2020
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
K202176
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 30d
Cleared Jun 22, 2020
GlidePath 10F Long-Term Dialysis Catheter
K200627
C.R. Bard, Inc.
Gastroenterology & Urology · 104d
Cleared Mar 05, 2020
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
K190527
C. R. Bard
Gastroenterology & Urology · 367d
Cleared May 31, 2019
Pristine Hemodialysis Catheter
K182443
Pristine Access Technologies , Ltd.
Gastroenterology & Urology · 266d
Cleared May 17, 2018
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
K173667
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 168d
Cleared Feb 08, 2018
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
K173805
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 55d
Cleared Nov 30, 2017
NexSite HD, Hemodialysis Step Tip Catheter (60cm)
K171571
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 184d
Cleared Nov 16, 2017
Symetrex Long Term Hemodialysis Catheter
K171618
Medcomp (Dba Medical Components, Inc.)
Gastroenterology & Urology · 167d
Cleared Aug 09, 2016
NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
K161026
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 119d
Cleared Apr 04, 2016
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
K151967
Merit Medical Systems, Inc.
Gastroenterology & Urology · 263d
Cleared Mar 31, 2015
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
K143567
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 105d
Cleared Nov 26, 2014
SYMETREX LONG TERM HEMODIALYSIS CATHETER
K140884
Phase One Medical
Gastroenterology & Urology · 233d
Cleared Nov 13, 2014
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
K140492
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 259d
Cleared Jul 07, 2014
VECTORFLOW
K141051
Arrow International, Inc.
Gastroenterology & Urology · 74d
Cleared Jun 18, 2014
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
K141363
Merit Medical Systems, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 28, 2014
SPLIT CATH RG
K130889
Medcomp
Gastroenterology & Urology · 395d
Cleared Feb 14, 2014
NMI DIALYSIS CATHETER
K131260
Navilyst Medical, Inc.
Gastroenterology & Urology · 288d
Cleared Jan 31, 2014
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),
K133796
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 49d

About Product Code MSD - Regulatory Context

510(k) Submission Activity

124 total 510(k) submissions under product code MSD since 1998, with 124 receiving FDA clearance (average review time: 139 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MSD Product Code

Recent submissions under MSD have taken an average of 347 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.

MSD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →