510(k) K970446 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Portland OR, US |
| Decision | Substantially Equivalent, Jun 2, 1997 |
| Received | Feb 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970446
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2011 | Baxter Healthcare Renal Div Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P.
Hemodialysis and Continuous Renal Rep Terminated |
KDI | None listed |
| 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 |
| Aug 24, 2005 | Baxter Healthcare Renal Div Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3TD, SYS1000L2C2; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
JPI | 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 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 |
FII | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.