FDA 510(k) Applications for Medical Device Product Code "FKT"
(System, Dialysate Delivery, Sorbent Regenerated)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K954623 | GAMBRO HEALTHCARE | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) | 08/28/1996 |
| K093362 | RENAL SOLUTIONS INC. | 2008 HEMODIALYSIS SORBENT SYSTEM | 08/13/2010 |
| K070739 | RENAL SOLUTIONS INC. | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | 05/25/2007 |
| K123835 | RENAL SOLUTIONS, INC. | 2008 HEMODIALYSIS SORBENT SYSTEM | 02/15/2013 |
| K043574 | RENAL SOLUTIONS, INC. | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | 06/03/2005 |
| K060381 | RENAL SOLUTIONS, INC. | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | 05/24/2006 |
| K031099 | RENAL SOLUTIONS, INC. | SORB+HISORB+CARTRIDGE | 09/17/2003 |
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