FDA Product Code FKT: System, Dialysate Delivery, Sorbent Regenerated
Leading manufacturers include Organon Teknika Corp., Renal Solutions, Inc. and Gambro Healthcare.
19
Total
19
Cleared
109d
Avg days
1980
Since
FDA 510(k) Cleared System, Dialysate Delivery, Sorbent Regenerated Devices (Product Code FKT)
19 devices
Cleared
Feb 15, 2013
2008 HEMODIALYSIS SORBENT SYSTEM
Renal Solutions, Inc.
Gastroenterology & Urology
64d
Cleared
Aug 13, 2010
2008 HEMODIALYSIS SORBENT SYSTEM
Renal Solutions, Inc.
Gastroenterology & Urology
289d
Cleared
May 25, 2007
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
Renal Solutions, Inc.
Gastroenterology & Urology
70d
Cleared
May 24, 2006
ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
Renal Solutions, Inc.
Gastroenterology & Urology
99d
Cleared
Jun 03, 2005
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000
Renal Solutions, Inc.
Gastroenterology & Urology
158d
Cleared
Aug 28, 1996
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
Gambro Healthcare
Gastroenterology & Urology
328d
Cleared
Oct 25, 1988
REDY 2000
Organon Teknika Corp.
Gastroenterology & Urology
134d
Cleared
Apr 12, 1985
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
Organon Teknika Corp.
Gastroenterology & Urology
43d
Cleared
Sep 12, 1984
HEMOPERFUSION PROCEDURE W/REDY 2000
Organon Teknika Corp.
Gastroenterology & Urology
78d
Cleared
Mar 23, 1982
SORB II
Organon Teknika Corp.
Gastroenterology & Urology
90d
Cleared
Dec 08, 1981
D-3260 SORBENT CARTRIDGE
Organon Teknika Corp.
Gastroenterology & Urology
55d
Cleared
Jul 31, 1981
D-3160 SORBENT CARTRIDGE
Organon Teknika Corp.
Gastroenterology & Urology
94d
Cleared
Jul 21, 1980
K1 POTASSIUM ACETATE ADDITIVE
Organon Teknika Corp.
Gastroenterology & Urology
38d
Cleared
Jul 21, 1980
SORB 10 DIALYSATE INFUSATE C1 INFUSATE
Organon Teknika Corp.
Gastroenterology & Urology
31d
Cleared
Jan 16, 1980
SORB SYSTEM URS
Organon Teknika Corp.
Gastroenterology & Urology
86d