FJI · Class II · 21 CFR 876.5820

FDA Product Code FJI: Dialyzer, Capillary, Hollow Fiber

Leading manufacturers include Gambro, Inc., National Medical Care, Medical Products Div., Inc. and Baxter Healthcare Corp.

131
Total
131
Cleared
127d
Avg days
1976
Since
131 devices
121–131 of 131
Cleared Apr 10, 1979
FLOW DIALYZER, CF 2300 CAPILLARY
K790067
Travenol Laboratories, S.A.
Gastroenterology & Urology · 88d
Cleared Feb 22, 1979
ARTIFICIAL KIDNEY, C-DAK 0.6D
K782151
Cordis Corp.
Gastroenterology & Urology · 58d
Cleared Sep 14, 1978
DISSCAP
K781142
Hospal Medical Corp.
Gastroenterology & Urology · 66d
Cleared Aug 23, 1978
C-DAK 4000 ARTIFICIAL KIDNEY
K781058
Cordis Corp.
Gastroenterology & Urology · 61d
Cleared Mar 15, 1978
DIALYZER, CAPILATORY, HOLLOW FIBER
K772290
Redy Laboratories
Gastroenterology & Urology · 93d
Cleared Jan 26, 1978
SPIRAFLOW DIALYZERS
K772423
Bentley Laboratories, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 15, 1977
CLIRANS TH 15 HOLLOW FIBER DIALYZER
K771694
Terumo America, Inc.
Gastroenterology & Urology · 9d
Cleared Jun 14, 1977
DIALYZER, FIBER, HOLLOW
K770867
Cobe Laboratories, Inc.
Gastroenterology & Urology · 33d
Cleared May 10, 1977
DIALYZER, FIBER, HOLLOW
K770734
Travenol Laboratories, S.A.
Gastroenterology & Urology · 19d
Cleared Jan 12, 1977
ARTIFICIAL KIDNEY, C-DAK CORDIS DOW
K761007
Cordis Corp.
Gastroenterology & Urology · 65d
Cleared Oct 15, 1976
DIALYZER, HF 130 HOLLOW FIBER
K760252
Cobe Laboratories, Inc.
Gastroenterology & Urology · 88d