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
73–96 of 131
Cleared Apr 25, 1985
DISSCAP 110 DIALYZER
K851380
Hospal Medical Corp.
Gastroenterology & Urology · 17d
Cleared Apr 03, 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-
K850865
Erika, Inc.
Gastroenterology & Urology · 33d
Cleared Mar 07, 1985
TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID
K850654
Erika, Inc.
Gastroenterology & Urology · 16d
Cleared Mar 07, 1985
TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2
K850655
Erika, Inc.
Gastroenterology & Urology · 16d
Cleared Jul 08, 1982
CLIRANS HOLLOW FIBER DIALYZERS
K820524
Terumo Medical Corp.
Gastroenterology & Urology · 132d
Cleared Jun 25, 1982
ERIKA HPF 50 DIALYZER
K821587
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Jun 23, 1982
HOLLOW FIBER DIALYZERS
K820743
Terumo Medical Corp.
Gastroenterology & Urology · 96d
Cleared Jun 22, 1982
ERIKA HPF 100,200,300 DIALYZER
K821690
Erika, Inc.
Gastroenterology & Urology · 14d
Cleared Mar 02, 1982
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
K820304
Gambro, Inc.
Gastroenterology & Urology · 26d
Cleared Sep 16, 1981
KF-E SERIES OF HOLLOW FIBER DIALYZERS
K812353
Medisystems Corp.
Gastroenterology & Urology · 28d
Cleared Feb 19, 1981
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY
K802894
Cordis Corp.
Gastroenterology & Urology · 94d
Cleared Feb 13, 1981
CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY
K802893
Cordis Corp.
Gastroenterology & Urology · 88d
Cleared Jan 07, 1981
C-PAK MODEL 12 ARTIFICIAL KIDNEY
K802613
Cordis Corp.
Gastroenterology & Urology · 78d
Cleared Dec 18, 1980
NEPHROSS DIALYZER
K802114
Organon Teknika Corp.
Gastroenterology & Urology · 106d
Cleared Dec 18, 1980
CLIRANS TH13 HOLLOW FIBER DIALYZER
K802122
Terumo America, Inc.
Gastroenterology & Urology · 105d
Cleared Dec 18, 1980
CLIRANS TH10 HOLLOW FIBER DIALYZER
K802441
Terumo America, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 12, 1980
DISSCAP HOLLOW FIBER DIALYZER
K802466
Hospal Medical Corp.
Gastroenterology & Urology · 35d
Cleared Sep 26, 1980
RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.
K801825
Renal Systems, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 26, 1980
RENAFLO HOLLOW FIBER DIALYZERS #MP 140
K801826
Renal Systems, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 26, 1980
RENAFLO HOLLOW FIBER DIALYZER #100.1
K801827
Renal Systems, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 12, 1980
CLIRANS TE10 HOLLOW FIBER DIALYZER
K801192
Terumo America, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 12, 1980
CLIRANS TE07 HOLLOW FIBER DIALYZER
K801194
Terumo America, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 28, 1980
COBE HF80, CAT. #18-580
K801178
Cobe Laboratories, Inc.
Gastroenterology & Urology · 70d
Cleared Jul 21, 1980
EXTRACORPOREALS' ALTERNATE MEMBRANE
K801344
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 46d