510(k) K954987 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
| Applicant | Althin Medical AB an Affiliate of Baxter Intl, Portland OR, US |
| Decision | Substantially Equivalent, Aug 8, 1996 |
| Received | Oct 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2009 | 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.
The Hemodialysis and Continuous Renal Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.