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
49–72 of 124
Cleared Oct 30, 2007
NOVOFLO CATHETER LT
K072499
Novosci, Inc.
Gastroenterology & Urology · 55d
Cleared Aug 22, 2007
15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
K071422
Rex Medical
Gastroenterology & Urology · 92d
Cleared Jun 26, 2007
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS
K070572
Ash Access Technology, Inc.
Gastroenterology & Urology · 118d
Cleared Feb 12, 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
K063441
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 08, 2007
HEMOCATH II
K062901
Med-Conduit, Inc.
Gastroenterology & Urology · 134d
Cleared Jan 29, 2007
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
K063431
Spire Biomedical, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 03, 2006
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
K062671
Kendall
Gastroenterology & Urology · 56d
Cleared Sep 01, 2006
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
K060288
Spire Biomedical, Inc.
Gastroenterology & Urology · 207d
Cleared Aug 04, 2006
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
K060972
Kendall
Gastroenterology & Urology · 119d
Cleared May 09, 2006
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
K060155
Spire Biomedical, Inc.
Gastroenterology & Urology · 109d
Cleared Apr 13, 2006
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
K053589
Bard Access Systems, Inc.
Gastroenterology & Urology · 111d
Cleared Nov 30, 2005
MEDCOMP SPLIT CATH II
K051280
Medcomp
Gastroenterology & Urology · 197d
Cleared Oct 06, 2005
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
K051584
Kendall
Gastroenterology & Urology · 113d
Cleared Aug 12, 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748
C.R. Bard, Inc.
Gastroenterology & Urology · 44d
Cleared Mar 23, 2005
14F DUAL FLOATING DIALYSIS CATHETER/TRAY
K042672
Cardio Med Supplies, Inc.
Gastroenterology & Urology · 175d
Cleared Mar 16, 2005
HEMOCATH
K043292
Med-Conduit, Inc.
Gastroenterology & Urology · 107d
Cleared Feb 03, 2005
MEDCOMP SPLIT-CATH II
K040318
Medcomp
Gastroenterology & Urology · 360d
Cleared Dec 22, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
K043272
Kendall
Gastroenterology & Urology · 26d
Cleared Dec 03, 2004
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
K042858
Spire Biomedical, Inc.
Gastroenterology & Urology · 49d
Cleared Nov 24, 2004
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
K040328
Medcomp
Gastroenterology & Urology · 288d
Cleared Sep 27, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
K041914
Kendall
Gastroenterology & Urology · 73d
Cleared Sep 23, 2004
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016
Datascope Corp.
Gastroenterology & Urology · 58d
Cleared Jul 30, 2004
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55
K041559
Spire Biomedical, Inc.
Gastroenterology & Urology · 50d
Cleared Jul 29, 2004
15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
K040992
Medcomp
Gastroenterology & Urology · 104d