510(k) K885281 ยท KRA Catheter, Continuous Flush
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Mar 3, 1989 |
| Received | Dec 27, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2009 | Edwards Lifesciences AG Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.) Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.