510(k) K013562 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Dec 12, 2002 |
| Received | Oct 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013562
| 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.