Panels › Gastroenterology, Urology › Product code FKT · Class 2
System, Dialysate Delivery, Sorbent Regenerated
Regulation 876.5600
0510(k)s in 12 months (19 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FKT
| Company | 510(k)s | Recalls |
|---|---|---|
| Organon Teknika Corp. | 9 | 0 |
| Renal Solutions, Inc. | 6 | 0 |
| Ash Medical Systems, Inc. | 3 | 0 |
| Gambro Healthcare | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 2013 | K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM Renal Solutions, Inc. | FKT |
| Aug 13, 2010 | K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM Renal Solutions, Inc. | FKT |
| May 25, 2007 | K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 Renal Solutions, Inc. | FKT |
| May 24, 2006 | K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 Renal Solutions, Inc. | FKT |
| Jun 3, 2005 | K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 Renal Solutions, Inc. | FKT |
| Sep 17, 2003 | K031099 | SORB+HISORB+CARTRIDGE Renal Solutions, Inc. | FKT |
| Aug 28, 1996 | K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) Gambro Healthcare | FKT |
| Oct 25, 1988 | K882428 | REDY 2000 Organon Teknika Corp. | FKT |
| Apr 8, 1988 | K874137 | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR Ash Medical Systems, Inc. | FKT |
| Feb 25, 1987 | K870270 | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. Ash Medical Systems, Inc. | FKT |
| Dec 11, 1986 | K864179 | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR Ash Medical Systems, Inc. | FKT |
| Apr 12, 1985 | K851188 | PACKETS FOR PREP. OF DIALYSATES & INFUSATES - Organon Teknika Corp. | FKT |
| Sep 12, 1984 | K842513 | HEMOPERFUSION PROCEDURE W/REDY 2000 Organon Teknika Corp. | FKT |
| Mar 23, 1982 | K813574 | SORB II Organon Teknika Corp. | FKT |
| Dec 8, 1981 | K812869 | D-3260 SORBENT CARTRIDGE Organon Teknika Corp. | FKT |
| Jul 31, 1981 | K811170 | D-3160 SORBENT CARTRIDGE Organon Teknika Corp. | FKT |
| Jul 21, 1980 | K801440 | SORB 10 DIALYSATE INFUSATE C1 INFUSATE Organon Teknika Corp. | FKT |
| Jul 21, 1980 | K801385 | K1 POTASSIUM ACETATE ADDITIVE Organon Teknika Corp. | FKT |
| Jan 16, 1980 | K792137 | SORB SYSTEM URS Organon Teknika Corp. | FKT |
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