510(k) K974652 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Jul 10, 1998 |
| Received | Dec 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974652
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a BM11A Blood Monitor Pump (5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module (5M3052/5M3052R), with Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.