510(k) K021615 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
BAXTER ACCURA SYSTEM, MODEL 5M5660
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Nov 18, 2002 |
| Received | May 16, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2005 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Ger Terminated |
KDI | None listed |
| Aug 18, 2005 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Ger Terminated |
KDI | None listed |
| Aug 11, 2004 | Baxter Healthcare Renal Div Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.