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
49–72 of 182
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 May 02, 1984
DIALYSIS ADMIN. SET - I.V.
K840654
Cp Medical
Gastroenterology & Urology · 77d
Cleared Apr 20, 1984
DIALYSIS TRAY
K841124
Medcare Products
Gastroenterology & Urology · 36d
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
Cleared Oct 14, 1983
NEPHROSS PRESTO
K832666
Organon Teknika Corp.
Gastroenterology & Urology · 66d
Cleared Oct 14, 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
K832894
Gambro, Inc.
Gastroenterology & Urology · 49d
Cleared Sep 29, 1983
SINGLE PATIENT SYS. II MODEL DM-450
K832053
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 94d
Cleared Sep 26, 1983
TISSUE FORCEPS
K831663
Medcare Products
Gastroenterology & Urology · 126d
Cleared Aug 26, 1983
CLIRANS TAF06 HOLLOW FIBER DIALYZER
K832252
Terumo Medical Corp.
Gastroenterology & Urology · 46d
Cleared Jun 24, 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
K831606
Gambro, Inc.
Gastroenterology & Urology · 37d
Cleared Jun 03, 1983
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &
K831482
Terumo Medical Corp.
Gastroenterology & Urology · 25d
Cleared Jun 02, 1983
EXTRASENSR ULTRAFILTRATION MONITOR
K831433
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 29d
Cleared May 27, 1983
LUNDIA 10-3-L PARALLEL FLOW DIALYZER
K831338
Gambro, Inc.
Gastroenterology & Urology · 32d