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 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
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831175
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831176
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared May 22, 1984
MAKS CENTRAL DELIVERY SYS-11-200 ETC
K840859
Erika, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 22, 1984
BSM 2000 DIALYSIS MACHINE
K840062
Organon Teknika Corp.
Gastroenterology & Urology · 73d
Cleared Feb 04, 1984
BLOOD TUBING
K834596
Renal Systems, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 04, 1984
EXP* 500 PARALLEL PLATE DIALYZER
K840057
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 04, 1984
EXP* 700 PARALLEL PLATE DIALYZER
K840146
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 22d
Cleared Jan 03, 1984
NEGATIVE PRESSURE ARTERIAL BLOOD
K833905
Erika, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 03, 1984
NEGATIVE PRESSURE VENOUS BLOOD LINE
K833906
Erika, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 27, 1983
DUAL LUMEN NEEDLE
K833308
Quinton, Inc.
Gastroenterology & Urology · 92d
Cleared Dec 14, 1983
ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF
K833252
Erika, Inc.
Gastroenterology & Urology · 85d
Cleared Dec 08, 1983
BLOOD SAFETY MODULE BSM2
K833440
Hospal Medical Corp.
Hematology · 64d
Cleared Dec 08, 1983
CLIRANS MODEL TAF 15 HOLLOW FIBER
K833503
Terumo Medical Corp.
Gastroenterology & Urology · 64d