FKP · Class II · 21 CFR 876.5820

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

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Baxter Healthcare Corp and Nxstage Medical, Inc..

50
Total
50
Cleared
141d
Avg days
1977
Since

FDA 510(k) Cleared System, Dialysate Delivery, Single Patient Devices (Product Code FKP)

50 devices
1–24 of 50
Cleared Sep 26, 2018
NxStage Connected Health System
K181991
Nxstage Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Feb 13, 1995
SPS 1550 SINGLE NEEDLE PATIENT SYSTEM
K922757
Baxter Healthcare Corp
Gastroenterology & Urology · 979d
Cleared Sep 07, 1989
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
K894838
Baxter Healthcare Corp
Gastroenterology & Urology · 38d
Cleared Feb 08, 1989
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111
Baxter Healthcare Corp
Gastroenterology & Urology · 198d
Cleared Jul 10, 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 32d
Cleared Apr 08, 1980
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM
K800330
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 55d
Cleared Jan 17, 1979
DIALYSATE DELIVERY SYSTEM
K781886
Cordis Corp.
Gastroenterology & Urology · 71d
Cleared Sep 15, 1977
EMODIALYSIS DEL. SYS. MODEL 7110
K771696
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 9d

About Product Code FKP - Regulatory Context