FIL · Class II · 21 CFR 876.5820

FDA Product Code FIL: System, Dialysate Delivery, Single Pass

Leading manufacturers include Travenol Laboratories, S.A., Gambro, Inc. and Extracorporeal Medical Specialities, Inc..

8
Total
8
Cleared
99d
Avg days
1977
Since

FDA 510(k) Cleared System, Dialysate Delivery, Single Pass Devices (Product Code FIL)

8 devices
1–8 of 8
Cleared Apr 19, 1990
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038
Baxter Healthcare Corp
Gastroenterology & Urology · 44d
Cleared May 11, 1989
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
K890329
Fresenius USA, Inc.
Gastroenterology & Urology · 108d
Cleared Dec 07, 1978
ULTRAFILTRATION SCALE
K781633
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 30, 1977
ULTRAFILTRATION MONITOR 5M9034
K771875
Travenol Laboratories, S.A.
Hematology · 56d
Cleared Aug 02, 1977
AK-10
K771227
Gambro, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 01, 1977
NEGATIVE PRESSURE ADAPTER 5M1350
K770137
Travenol Laboratories, S.A.
Gastroenterology & Urology · 8d

About Product Code FIL - Regulatory Context