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
73–96 of 124
Cleared May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736
Boston Scientific Corp
Gastroenterology & Urology · 57d
Cleared May 14, 2004
STEP-TIP CHRONIC HEMODIALYSIS CATHETER
K040666
Arrow International, Inc.
Gastroenterology & Urology · 60d
Cleared Apr 19, 2004
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
K040402
AngioDynamics, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 19, 2004
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
K040509
Spire Biomedical, Inc.
Gastroenterology & Urology · 52d
Cleared Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492
Boston Scientific Corp
Gastroenterology & Urology · 19d
Cleared Feb 13, 2004
CANNON II PLUS
K040078
Arrow International, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 23, 2003
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH
K032061
Spire Biomedical, Inc.
Gastroenterology & Urology · 173d
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 May 20, 2003
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
K030502
Medcomp
Gastroenterology & Urology · 90d
Cleared May 09, 2003
DIATEK CANNON-CATHETER, MODEL CC5500
K022662
Arrow Intl., Inc.
Gastroenterology & Urology · 273d
Cleared Feb 24, 2003
MEDCOMP SC4
K022678
Medcomp
Gastroenterology & Urology · 196d
Cleared Dec 13, 2002
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
K022905
Horizon Medical Products, Inc.
Gastroenterology & Urology · 101d
Cleared Oct 11, 2002
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL
K020936
Medcomp
Gastroenterology & Urology · 203d
Cleared Aug 27, 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
K021759
Medcomp
Gastroenterology & Urology · 90d
Cleared Jul 19, 2002
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
K022000
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
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 May 17, 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
K021212
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 11, 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
K013160
Spire Biomedical, Inc.
Gastroenterology & Urology · 202d
Cleared Feb 08, 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562
Medical Components, Inc.
Gastroenterology & Urology · 184d
Cleared Oct 31, 2001
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
K011916
Horizon Medical Products, Inc.
Gastroenterology & Urology · 133d