MSD · Class II · 21 CFR 876.5540

FDA Product Code MSD: Catheter, Hemodialysis, Implanted

Leading manufacturers include Medcomp, C.R. Bard, Inc. and Medical Components, Inc..

124
Total
124
Cleared
139d
Avg days
1998
Since
124 devices
49–72 of 124
Cleared Aug 27, 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
K021759
Medcomp
Gastroenterology & Urology · 90d
Cleared May 24, 2002
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
K020315
Medcomp
Gastroenterology & Urology · 115d
Cleared May 22, 2002
MEDCOMP ASH SPLIT-CATH II
K020465
Medcomp
Gastroenterology & Urology · 99d
Cleared Feb 08, 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562
Medical Components, Inc.
Gastroenterology & Urology · 184d
Cleared Oct 03, 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
K010306
Medcomp
Gastroenterology & Urology · 244d
Cleared Oct 03, 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105
Medical Components, Inc.
Gastroenterology & Urology · 667d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Jun 12, 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207
Medical Components, Inc.
Gastroenterology & Urology · 242d
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
Cleared Feb 26, 1999
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
K981125
Medical Components, Inc.
Gastroenterology & Urology · 336d
Cleared Feb 12, 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
K982333
Cook, Inc.
Gastroenterology & Urology · 225d
Cleared Nov 25, 1998
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
K981365
Sherwood Medical Co.
Gastroenterology & Urology · 224d
Cleared Sep 03, 1998
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER
K981994
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Feb 23, 1998
MEDCOMP BIO-FLEX CS CATHETER (CS100)
K971925
Medical Components, Inc.
Gastroenterology & Urology · 276d
Cleared Feb 23, 1998
MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM
K972207
Medcomp
Gastroenterology & Urology · 256d