FIF · Class II · 21 CFR 876.5820

FDA Product Code FIF: Set, Dialysis, Single Needle With Uni-directional Pump

Leading manufacturers include Extracorporeal Medical Specialities, Inc., Medical Components, Inc. and Cobe Laboratories, Inc..

6
Total
6
Cleared
49d
Avg days
1977
Since

FDA 510(k) Cleared Set, Dialysis, Single Needle With Uni-directional Pump Devices (Product Code FIF)

6 devices
1–6 of 6
Cleared Mar 23, 1982
COBE SINGLE-NEEDLE CONTROLLER #18-756
K820173
Cobe Laboratories, Inc.
Gastroenterology & Urology · 61d
Cleared Sep 26, 1980
MEDCOMP FEMORAL VEIN CATHETER
K801967
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Nov 16, 1979
MODEL DM 353 & DM-353-L SINGLE NEEDLE
K792174
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 18d
Cleared Nov 28, 1977
GW 35 GUIDE WIRE
K772147
Sorensen Research
Hematology · 14d

About Product Code FIF - Regulatory Context