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
73–96 of 182
Cleared Apr 06, 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
K830905
Gambro, Inc.
Gastroenterology & Urology · 16d
Cleared Mar 29, 1983
AMPCO KIDNEY DIALYSIS TRAY
K823839
Associated Medical Products Co.
Gastroenterology & Urology · 98d
Cleared Mar 29, 1983
C-DAK ARTIFICIAL KIDNEY
K830729
Cordis Corp.
Gastroenterology & Urology · 21d
Cleared Feb 16, 1983
KF-101-07 DIALYZER
K822337
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
KF-101-10 DIALYZER
K822338
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 196d
Cleared Feb 16, 1983
KF-101-13 DIALYZER
K822339
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 196d
Cleared Jan 26, 1983
MEDISYSTEMS FISTULA NEEDLES
K823068
Medisystems Corp.
Gastroenterology & Urology · 99d
Cleared Jan 21, 1983
KF-E SERIES HOLLOW FIBER DIALYZER
K823069
Medisystems Corp.
Gastroenterology & Urology · 94d
Cleared Jan 14, 1983
A.V. FISTULA CANNULATION SETS
K830021
Travenol Laboratories, S.A.
Gastroenterology & Urology · 10d
Cleared Jan 12, 1983
LUNDIA 10-5-L PARRALLE FLOW DIALYZER
K823791
Gambro, Inc.
Gastroenterology & Urology · 27d
Cleared Jan 12, 1983
CAPILLARY FLOW DIALYZERS
K823826
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 07, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K823778
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 05, 1983
HOSPAL BLOOD LINES
K823707
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Dec 16, 1982
RENAFLO II
K823546
Renal Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 07, 1982
NEPHROSS, ANDANTE H.F.
K823375
Organon Teknika Corp.
Gastroenterology & Urology · 25d
Cleared Nov 03, 1982
EXTRACORPOREAL SINGLE NEEDLE MODULE
K822340
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 91d
Cleared Oct 18, 1982
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K822796
Erika, Inc.
Gastroenterology & Urology · 32d
Cleared Sep 24, 1982
TRIEX-IH DIALYZER
K822738
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 27, 1982
TS-000 ARTERIOVENOUS BLOOD TUBING SET
K822283
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 16, 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049
Gambro, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 16, 1982
ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
K822225
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 16, 1982
ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
K822226
Erika, Inc.
Gastroenterology & Urology · 20d
Cleared May 28, 1982
GF-180-M & GF-180-H HEMODIALYZERS
K821367
Gambro, Inc.
Gastroenterology & Urology · 18d
Cleared May 27, 1982
DISPOSABLE BLOOD LINE CONNECTORS
K821495
Bentley Laboratories, Inc.
Hematology · 8d