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
97–120 of 131
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 Oct 31, 1980
HOLLO FIBER DIALYZER
K801559
Renal Devices, Inc.
Gastroenterology & Urology · 115d
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
Cleared Jul 21, 1980
GF-120-L DIALYZER
K801370
Gambro, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 30, 1980
GF120H DIALYZER
K801045
Gambro, Inc.
Gastroenterology & Urology · 56d
Cleared May 08, 1980
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704
Cordis Corp.
Gastroenterology & Urology · 38d
Cleared May 02, 1980
GAMBRO LUNDIA FIBER
K800336
Gambro, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 10, 1980
MODEL TRIEX-L HOLLOW FIBER DIALYZER
K800549
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 31d
Cleared Feb 26, 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221
Travenol Laboratories, S.A.
Gastroenterology & Urology · 22d
Cleared Feb 26, 1980
TRIEX-2 HOLLOW FIBER DIALYZER
K800270
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 20d
Cleared Jan 16, 1980
C-DAK 2100 ARTIFICIAL KIDNEY
K792419
Cordis Corp.
Gastroenterology & Urology · 50d
Cleared Sep 24, 1979
ERIKA HPF 100
K791320
Erika, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 24, 1979
ERIKA HPF 200
K791321
Erika, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 24, 1979
ERIKA HPF 300
K791322
Erika, Inc.
Gastroenterology & Urology · 74d
Cleared Jun 20, 1979
RDI-1 HOLLOW FIBER DIALYZER
K790696
Renal Devices, Inc.
Gastroenterology & Urology · 71d
Cleared May 01, 1979
DISPOSABLE DIALYZERS, SD-ID, SD-2D
K790308
Bentley Laboratories, Inc.
Gastroenterology & Urology · 77d