510(k) K051253 ยท MEA Pump, Infusion, Pca
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Jul 15, 2005 |
| Received | May 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2015 | Baxter Healthcare Corp. The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand. Terminated |
MEA | None listed |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Regional Analgesia Infusor System with Patient Control.
Indicated for the intravenous administration of medications. Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.