510(k) K022203 ยท MEA Pump, Infusion, Pca
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 1, 2002 |
| Received | Jul 5, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2009 | Hospira Inc LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 12384-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Terminated |
FRN | None listed |
| Mar 9, 2006 | Hospira Inc Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09 Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.