FKT · Class II · 21 CFR 876.5600

FDA Product Code FKT: System, Dialysate Delivery, Sorbent Regenerated

Leading manufacturers include Organon Teknika Corp..

19
Total
19
Cleared
109d
Avg days
1980
Since

FDA 510(k) Cleared System, Dialysate Delivery, Sorbent Regenerated Devices (Product Code FKT)

19 devices
1–19 of 19
Cleared Oct 25, 1988
REDY 2000
K882428
Organon Teknika Corp.
Gastroenterology & Urology · 134d
Cleared Apr 12, 1985
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
K851188
Organon Teknika Corp.
Gastroenterology & Urology · 43d
Cleared Sep 12, 1984
HEMOPERFUSION PROCEDURE W/REDY 2000
K842513
Organon Teknika Corp.
Gastroenterology & Urology · 78d
Cleared Mar 23, 1982
SORB II
K813574
Organon Teknika Corp.
Gastroenterology & Urology · 90d
Cleared Dec 08, 1981
D-3260 SORBENT CARTRIDGE
K812869
Organon Teknika Corp.
Gastroenterology & Urology · 55d
Cleared Jul 31, 1981
D-3160 SORBENT CARTRIDGE
K811170
Organon Teknika Corp.
Gastroenterology & Urology · 94d
Cleared Jul 21, 1980
K1 POTASSIUM ACETATE ADDITIVE
K801385
Organon Teknika Corp.
Gastroenterology & Urology · 38d
Cleared Jul 21, 1980
SORB 10 DIALYSATE INFUSATE C1 INFUSATE
K801440
Organon Teknika Corp.
Gastroenterology & Urology · 31d
Cleared Jan 16, 1980
SORB SYSTEM URS
K792137
Organon Teknika Corp.
Gastroenterology & Urology · 86d

About Product Code FKT - Regulatory Context