510(k) K921994 ยท MEA Pump, Infusion, Pca
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
| Applicant | C.R. Bard, Inc., North Reading MA, US |
| Decision | Substantially Equivalent, Aug 3, 1992 |
| Received | Apr 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921994
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2006 | Baxter Healthcare Corp. Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.