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
49–72 of 131
Cleared Sep 15, 1988
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
K881811
Cobe Laboratories, Inc.
Gastroenterology & Urology · 140d
Cleared Aug 12, 1988
MODIFIED TORAY FILTRYZER DIALYZERS
K882158
Toray Industries (America), Inc.
Gastroenterology & Urology · 81d
Cleared Jul 22, 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680
Baxter Healthcare Corp
Gastroenterology & Urology · 23d
Cleared Jun 28, 1988
NEPHROSS I.Q. ALLEGO
K882213
Organon Teknika Corp.
Gastroenterology & Urology · 33d
Cleared Jun 28, 1988
NEPHROSS I.Q. MODERATO
K882215
Organon Teknika Corp.
Gastroenterology & Urology · 33d
Cleared Jun 28, 1988
BIO*NEPHROSS I.Q. ANDANTE
K882339
Organon Teknika Corp.
Gastroenterology & Urology · 22d
Cleared Feb 19, 1988
FRESENIUS HEMOFLOW F3, F4, F5, F7
K874872
Seratronics, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 19, 1988
GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
K880084
Gambro, Inc.
Gastroenterology & Urology · 38d
Cleared Jan 29, 1988
NEPHROSS I.Q. ANDANTE
K874549
Organon Teknika Corp.
Gastroenterology & Urology · 86d
Cleared Jan 29, 1988
CAPILLARY FLOW DIALYZERS
K874728
Baxter Healthcare Corp
Gastroenterology & Urology · 72d
Cleared Jan 27, 1988
GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
K880083
Gambro, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 12, 1987
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471
Travenol Laboratories, S.A.
Gastroenterology & Urology · 59d
Cleared May 29, 1987
HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H
K871236
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 63d
Cleared May 01, 1987
FRESENIUS HEMOFLOW F6 AND F8
K870725
Seratronics, Inc.
Gastroenterology & Urology · 66d
Cleared Apr 06, 1987
CAPILLARY FLOW DIALYZERS
K870169
Travenol Laboratories, S.A.
Gastroenterology & Urology · 82d
Cleared Mar 27, 1987
CAPILLARY FLOW HOLLOW FIBER DIALYZERS
K863044
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 228d
Cleared Mar 27, 1987
COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS
K864831
Cobe Laboratories, Inc.
Gastroenterology & Urology · 108d
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 Dec 13, 1985
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280
Terumo Medical Corp.
Gastroenterology & Urology · 51d
Cleared Sep 11, 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591
Organon Teknika Corp.
Gastroenterology & Urology · 15d