510(k) K030099 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Jun 17, 2003 |
| Received | Jan 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030099
| 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 |
| 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 |
| Aug 24, 2005 | Baxter Healthcare Renal Div Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
KDI | None listed |
| Dec 24, 2004 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FII | None listed |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.