KOC · Class II · 21 CFR 876.5820

FDA Product Code KOC: Accessories, Blood Circuit, Hemodialysis

Leading manufacturers include Sorensen Research, Erika, Inc. and Extracorporeal Medical Specialities, Inc..

182
Total
182
Cleared
105d
Avg days
1976
Since
182 devices
25–48 of 182
Cleared Feb 16, 1995
DIAL MEDICAL KIT
K941543
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 323d
Cleared Oct 07, 1994
SILICONE CATHETER REPAIR KITS
K926374
Akcess Medical Products, Inc.
Gastroenterology & Urology · 654d
Cleared Mar 15, 1994
BARD UROTRACK II MONITORING
K924436
C.R. Bard, Inc.
Gastroenterology & Urology · 560d
Cleared Jun 09, 1993
RS-1000
K911230
Cp Medical
Gastroenterology & Urology · 812d
Cleared Mar 31, 1992
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374
C.R. Bard, Inc.
Gastroenterology & Urology · 307d
Cleared Oct 30, 1991
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315
Baxter Healthcare Corp
Gastroenterology & Urology · 218d
Cleared Sep 27, 1991
MINNILERT(R) PRESSURE MONITOR
K913483
Minntech Corp.
Gastroenterology & Urology · 52d
Cleared May 28, 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106
Baxter Healthcare Corp
Gastroenterology & Urology · 77d
Cleared Apr 29, 1991
INTRODUCER NEEDLES
K910641
Akcess Medical Products, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 16, 1991
Y ADAPTOR
K910321
Akcess Medical Products, Inc.
Gastroenterology & Urology · 82d
Cleared Feb 12, 1990
MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
K895244
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 175d
Cleared Feb 09, 1990
JMS DIALYZER PRIMING SET
K895882
Jms Co., Ltd.
Gastroenterology & Urology · 127d
Cleared Dec 27, 1989
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006
Baxter Healthcare Corp
Gastroenterology & Urology · 75d
Cleared Sep 22, 1989
NATIONAL MEDICAL CARE VENOUS LINE 03-9548
K894637
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 60d
Cleared Jun 26, 1986
FAST FORMALERT
K853555
Organon Teknika Corp.
Gastroenterology & Urology · 304d
Cleared Jun 12, 1985
BSM 22 BLOOD SAFETY MODULE
K852134
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Jun 12, 1985
BSM 21 BLOOD SAFETY MODULE
K852135
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Nov 16, 1984
ASN MONITOR SINGLE NEEDLE MONITOR
K843531
Organon Teknika Corp.
Gastroenterology & Urology · 70d
Cleared Oct 18, 1984
HOLLOW FIBER DIALYZER
K843632
Travenol Laboratories, S.A.
Gastroenterology & Urology · 31d
Cleared Sep 12, 1984
CAPILLARY FLOW DIALYZERS
K840937
Travenol Laboratories, S.A.
Gastroenterology & Urology · 191d
Cleared Aug 16, 1984
HOLLOW FIBER DIALYZERS
K840845
Travenol Laboratories, S.A.
Gastroenterology & Urology · 174d
Cleared Jul 13, 1984
ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
K842436
Erika, Inc.
Gastroenterology & Urology · 23d
Cleared Jun 22, 1984
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER
K831173
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIFICIAL KID-
K831174
Erika, Inc.
Gastroenterology & Urology · 438d