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 May 11, 1989
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
K892523
Gambro, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 17, 1989
TORAY FILTRYZER DIALYZERS
K884339
Toray Industries (America), Inc.
Gastroenterology & Urology · 154d
Cleared Feb 08, 1989
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
K890111
Gambro, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 31, 1989
RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS
K883748
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 152d
Cleared Oct 21, 1988
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100
K883534
Baxter Healthcare Corp
Gastroenterology & Urology · 64d
Cleared Oct 21, 1988
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170
K883644
Baxter Healthcare Corp
Gastroenterology & Urology · 57d
Cleared Sep 29, 1988
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
K883589
Gambro, Inc.
Gastroenterology & Urology · 38d
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