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
97–120 of 182
Cleared Sep 29, 1981
CLIRANS TE12 HOLLOW FIBER DIALYZER
K812498
Terumo Medical Corp.
Gastroenterology & Urology · 29d
Cleared Aug 04, 1981
ISOLATER THP
K811981
Tri-Med, Inc.
Gastroenterology & Urology · 22d
Cleared Jul 31, 1981
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
K811977
Renal Systems, Inc.
Gastroenterology & Urology · 18d
Cleared Mar 13, 1981
SCANLAN SUTURE BOOTS
K810480
Scanlan Intl., Inc.
Hematology · 18d
Cleared Jul 08, 1980
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K801355
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
K801356
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Nov 13, 1979
COAXIAL DUAL FLOW CATHETER
K791411
Terumo America, Inc.
Gastroenterology & Urology · 109d
Cleared Jun 27, 1979
TG 2, TRI-GARD PRESSURE MONITOR
K790841
Sorensen Research
Gastroenterology & Urology · 56d
Cleared May 02, 1979
HEMODIALYSIS BLOOD CIRCUIT
K790591
Travenol Laboratories, S.A.
Gastroenterology & Urology · 37d
Cleared Apr 20, 1979
ARTERIOVENOUS SETS
K790381
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 52d
Cleared Aug 26, 1977
TUBE OCCLUDING FORCEPS
K771424
Quinton, Inc.
Gastroenterology & Urology · 25d
Cleared Apr 28, 1977
GAMBRO VENOUS BLOOD LINE
K770691
Gambro, Inc.
Gastroenterology & Urology · 14d
Cleared Mar 30, 1977
TRANSDUCER PROTECTOR, RT-901, RT-902
K770524
Renal Systems, Inc.
Gastroenterology & Urology · 12d
Cleared Mar 16, 1977
PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2
K770475
Travenol Laboratories, S.A.
Gastroenterology & Urology · 5d
Cleared Mar 08, 1977
NEEDLE, FISTULA, ERIKA
K770382
Erika, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 07, 1977
STOPCOCK, ONE WAY
K770383
Cobe Laboratories, Inc.
Gastroenterology & Urology · 7d
Cleared Feb 07, 1977
BARIOR
K770213
Tri-Med, Inc.
Gastroenterology & Urology · 5d
Cleared Jan 14, 1977
DNC 161 VINCA-FLO
K770043
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 141 VINCA-FLO
K770044
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 152 VINCA-FLO
K770045
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 142 VINCA-FLO
K770046
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Jan 14, 1977
DNC 162 VINCA-FLO
K770048
Sorensen Research
Gastroenterology & Urology · 4d
Cleared Dec 06, 1976
SINGLE NEEDLE HEMODIALYSIS
K761038
Sorensen Research
Gastroenterology & Urology · 21d