FII · Class II · 21 CFR 876.5860

FDA Product Code FII: System, Dialysate Delivery, Sealed

Leading manufacturers include Gambro, Inc., Nxstage Medical, Inc. and Hospal Medical Corp..

5
Total
5
Cleared
105d
Avg days
1982
Since

FDA 510(k) Cleared System, Dialysate Delivery, Sealed Devices (Product Code FII)

5 devices
1–5 of 5
Cleared Jul 07, 2003
NXSTAGE SYSTEM ONE
K030470
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Aug 24, 1988
GAMBRO MULTIPURPOSE SYSTEM MPS-10
K881270
Gambro, Inc.
Gastroenterology & Urology · 153d
Cleared Oct 13, 1987
HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
K872364
Travenol Laboratories, S.A.
Gastroenterology & Urology · 117d
Cleared Sep 09, 1986
HEMOFILTRATION SYSTEM 10
K862716
Gambro, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 06, 1982
COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA
K822386
Hospal Medical Corp.
Gastroenterology & Urology · 58d

About Product Code FII - Regulatory Context