510(k) K911315 ยท KOC Accessories, Blood Circuit, Hemodialysis
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Oct 30, 1991 |
| Received | Mar 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2006 | Baxter Healthcare Renal Div Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R Terminated |
KOC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.