FKP · Class II · 21 CFR 876.5820

FDA Product Code FKP: System, Dialysate Delivery, Single Patient

Leading manufacturers include Gambro, Inc., Nxstage Medical, Inc. and Extracorporeal Medical Specialities, Inc..

50
Total
50
Cleared
141d
Avg days
1977
Since
50 devices
25–48 of 50
Cleared Feb 28, 1985
MBM(TM) MONITRAL (R) BICARBONATE MODULE
K850179
Hospal Medical Corp.
Gastroenterology & Urology · 42d
Cleared Nov 16, 1981
EXTRASENSR ULTRAFILTRATION MONITOR
K811972
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 10, 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 32d
Cleared Dec 17, 1980
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
K802880
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 10, 1980
DIALYSIS CONTROL UNIT-CENTRY 2000
K802250
Cobe Laboratories, Inc.
Gastroenterology & Urology · 85d
Cleared Apr 08, 1980
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM
K800330
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 55d
Cleared Apr 08, 1980
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION
K800425
Gambro, Inc.
Gastroenterology & Urology · 42d
Cleared Nov 16, 1979
MODELS DM-360 & DM-350-L SINGLE PATIENT
K792173
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 18d
Cleared Jan 17, 1979
DIALYSATE DELIVERY SYSTEM
K781886
Cordis Corp.
Gastroenterology & Urology · 71d
Cleared Dec 07, 1978
SUITCASE KIDNEY HEMODIALYSIS SYSTEM
K781405
Union Carbide Corp.
Gastroenterology & Urology · 115d
Cleared Jun 22, 1978
SINGLE PATIENT SYSTEMS
K780682
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 59d
Cleared Sep 15, 1977
EMODIALYSIS DEL. SYS. MODEL 7110
K771696
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 9d
Cleared Jan 03, 1977
5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY
K761287
Travenol Laboratories, S.A.
Gastroenterology & Urology · 14d