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 Sep 25, 1986
DISSCAP 80E, 110E, 140E, 160E
K863592
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Jul 22, 1986
TORAY FILTRYZER DIALYZER, B1-2.0.
K862693
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 11d
Cleared Jul 10, 1986
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7
K861536
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 77d
Cleared Jul 10, 1986
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5
K861537
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 77d
Cleared Jul 10, 1986
ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER
K861916
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 52d
Cleared Jan 21, 1986
ASAHI AM SERIES DIALYZERS
K855212
Advocacy International, Ltd.
Gastroenterology & Urology · 22d
Cleared Dec 13, 1985
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280
Terumo Medical Corp.
Gastroenterology & Urology · 51d
Cleared Dec 02, 1985
MODIFIED AM-SERIES DIALYZERS
K854575
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Sep 11, 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591
Organon Teknika Corp.
Gastroenterology & Urology · 15d
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
HF-100 DIALYZER
K802092
Bio-Med Corp.
Gastroenterology & Urology · 107d
Cleared Dec 18, 1980
NEPHROSS DIALYZER
K802114
Organon Teknika Corp.
Gastroenterology & Urology · 106d