MSD · Class II · 21 CFR 876.5540

FDA Product Code MSD: Catheter, Hemodialysis, Implanted

Leading manufacturers include C.R. Bard, Inc., Boston Scientific Corp and Medical Components, Inc. (dba MedComp).

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 May 28, 2009
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT
K090528
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 10, 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101
C.R. Bard, Inc.
Gastroenterology & Urology · 26d
Cleared Aug 12, 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748
C.R. Bard, Inc.
Gastroenterology & Urology · 44d
Cleared May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736
Boston Scientific Corp
Gastroenterology & Urology · 57d
Cleared Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492
Boston Scientific Corp
Gastroenterology & Urology · 19d
Cleared Nov 26, 2003
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294
C.R. Bard, Inc.
Gastroenterology & Urology · 43d
Cleared Oct 02, 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Aug 06, 2003
SOFT-CELL DUAL LUMEN CATHETERS
K030277
C.R. Bard, Inc.
Gastroenterology & Urology · 191d
Cleared Jun 16, 2003
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
K030020
C.R. Bard, Inc.
Gastroenterology & Urology · 164d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326
Boston Scientific Corp
Gastroenterology & Urology · 375d

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 →