510(k) K910215 ยท FKP System, Dialysate Delivery, Single Patient
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
| Applicant | Cd Medical, Inc., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Apr 9, 1991 |
| Received | Jan 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910215
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2006 | Baxter Healthcare Renal Div Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; Baxter Healthcare C Terminated |
KDI | None listed |
| Apr 18, 2006 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FKP | None listed |
| Jan 6, 2006 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
KDI | None listed |
| Dec 2, 2004 | Baxter Healthcare Renal Div Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Cor Terminated |
FKP | None listed |
| May 15, 2003 | Baxter Healthcare Corp. Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Cor Terminated |
FKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.