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
124 devices
25–48 of 124
Cleared Jan 09, 2014
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K130851
Health Line International Corporation
Gastroenterology & Urology · 288d
Cleared Jul 26, 2013
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
K131814
Ameco Medical Industries
Gastroenterology & Urology · 36d
Cleared May 10, 2013
NEXTSTEP RETROGRADE
K130192
Arrow International, Inc.
Gastroenterology & Urology · 105d
Cleared Apr 02, 2013
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
K123943
Ameco Medical Industries
Gastroenterology & Urology · 103d
Cleared Mar 14, 2013
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
K121933
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 255d
Cleared Jan 31, 2013
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
K123196
Covidien
Gastroenterology & Urology · 112d
Cleared Sep 21, 2012
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
K121848
Medical Components, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 09, 2012
HEMO-CATH 10F, HEMO-CATH 12.5F
K113487
Medical Components, Inc.
Gastroenterology & Urology · 107d
Cleared Dec 08, 2011
SPLIT CATH III
K111651
Medical Components, Inc.
Gastroenterology & Urology · 178d
Cleared Aug 30, 2011
PALINDROME RT CHRONIC CATHETER
K111817
Covidien
Gastroenterology & Urology · 64d
Cleared Aug 17, 2011
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K111900
Teleflexmedical, Inc.
Gastroenterology & Urology · 43d
Cleared Aug 04, 2011
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
K111372
Covidien
Gastroenterology & Urology · 80d
Cleared Jun 30, 2011
CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
K111117
Teleflexmedical, Inc.
Gastroenterology & Urology · 70d
Cleared Jun 10, 2011
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
K110936
AngioDynamics, Inc.
Gastroenterology & Urology · 67d
Cleared Feb 01, 2011
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K102238
Teleflexmedical, Inc.
Gastroenterology & Urology · 176d
Cleared Oct 20, 2010
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
K101843
AngioDynamics, Inc.
Gastroenterology & Urology · 111d
Cleared Jan 08, 2010
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
K091506
R4 Vascular, Inc.
Gastroenterology & Urology · 232d
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 Apr 13, 2009
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148
Merit Medical Systems, Inc.
Gastroenterology & Urology · 82d
Cleared Feb 10, 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101
C.R. Bard, Inc.
Gastroenterology & Urology · 26d
Cleared May 13, 2008
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
K080400
AngioDynamics, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 29, 2008
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
K073092
Spire Biomedical, Inc.
Gastroenterology & Urology · 89d
Cleared Jan 22, 2008
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
K073093
Spire Biomedical, Inc.
Gastroenterology & Urology · 82d
Cleared Nov 30, 2007
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
K071202
Dermaport, Inc.
Gastroenterology & Urology · 213d