FJI · Class II · 21 CFR 876.5820

FDA Product Code FJI: Dialyzer, Capillary, Hollow Fiber

Leading manufacturers include Baxter Healthcare Corp, Cordis Corp. and Travenol Laboratories, S.A..

131
Total
131
Cleared
127d
Avg days
1976
Since

FDA 510(k) Cleared Dialyzer, Capillary, Hollow Fiber Devices (Product Code FJI)

131 devices
1–24 of 131
Cleared Aug 23, 2019
Hemoflow F3 and F4 Dialyzers
K190459
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 178d
Cleared May 19, 1998
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933
Baxter Healthcare Corp
Gastroenterology & Urology · 419d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Jan 11, 1995
BAXTER CA DIALYZER
K926567
Baxter Healthcare Corp
Gastroenterology & Urology · 741d
Cleared Dec 10, 1990
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228
Baxter Healthcare Corp
Gastroenterology & Urology · 20d
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 Jul 22, 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680
Baxter Healthcare Corp
Gastroenterology & Urology · 23d
Cleared Jan 29, 1988
CAPILLARY FLOW DIALYZERS
K874728
Baxter Healthcare Corp
Gastroenterology & Urology · 72d
Cleared Jun 12, 1987
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471
Travenol Laboratories, S.A.
Gastroenterology & Urology · 59d
Cleared Apr 06, 1987
CAPILLARY FLOW DIALYZERS
K870169
Travenol Laboratories, S.A.
Gastroenterology & Urology · 82d
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 May 08, 1980
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704
Cordis Corp.
Gastroenterology & Urology · 38d
Cleared Feb 26, 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221
Travenol Laboratories, S.A.
Gastroenterology & Urology · 22d
Cleared Jan 16, 1980
C-DAK 2100 ARTIFICIAL KIDNEY
K792419
Cordis Corp.
Gastroenterology & Urology · 50d
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 Aug 23, 1978
C-DAK 4000 ARTIFICIAL KIDNEY
K781058
Cordis Corp.
Gastroenterology & Urology · 61d
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

About Product Code FJI - Regulatory Context