FHS · Class II · 21 CFR 876.5820

FDA Product Code FHS: Dialyzer, Single Coil

Leading manufacturers include Erika, Inc., Travenol Laboratories, S.A. and Gambro, Inc..

12
Total
12
Cleared
57d
Avg days
1976
Since

FDA 510(k) Cleared Dialyzer, Single Coil Devices (Product Code FHS)

12 devices
1–12 of 12
Cleared Dec 03, 1981
MICROCOIL 80 DIALYZER
K812811
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Sep 16, 1981
MICROCOIL 150 DIALYZER
K811974
Erika, Inc.
Hematology · 65d
Cleared May 14, 1980
MICRO-COIL 100 COIL DIALYZER
K800723
Erika, Inc.
Gastroenterology & Urology · 43d
Cleared Feb 13, 1980
GAMBRO LUNDIA COIL DIALYZER
K800174
Gambro, Inc.
Gastroenterology & Urology · 19d
Cleared Mar 26, 1979
DIALYZER, CD-800 COIL
K790223
Travenol Laboratories, S.A.
Gastroenterology & Urology · 52d
Cleared Oct 17, 1978
DIALYZER, DISP., COIL, LUNDIA
K781102
Gambro, Inc.
Gastroenterology & Urology · 106d
Cleared Aug 02, 1977
MODIFICATION TO KIDNEY DIALYZER
K771349
Erika, Inc.
Gastroenterology & Urology · 12d
Cleared May 10, 1977
DIALYZER, COIL, CD, LSA, 5M1765
K770735
Travenol Laboratories, S.A.
Gastroenterology & Urology · 19d
Cleared Jan 10, 1977
COIL DIALYZER MODEL ALT 140
K761358
Bentley Laboratories, Inc.
Gastroenterology & Urology · 12d
Cleared Nov 19, 1976
ERI-FLO 900 DIALYZER
K760702
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Oct 27, 1976
DIALYZER (MODEL 1850)
K760374
Erika, Inc.
Gastroenterology & Urology · 83d

About Product Code FHS - Regulatory Context