510(k) K910425 ยท FRN Pump, Infusion
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Apr 1, 1991 |
| Received | Jan 31, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Intermate Infusion Pump.
Indicated for the intravenous administration of medications. Terminated |
FRN | None listed |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: SV Elastomeric Infusion Device.
Indicated for the intravenous administration of medications. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.