510(k) K781036 ยท FPA Set, Administration, Intravascular
AUTO-SYRINGE INFUSION SET
| Applicant | Baxter Healthcare Corp, Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 10, 1978 |
| Received | Jun 19, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 1M8450
For the administ Terminated |
FPA | None listed |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 43" (64 cm), 0.24 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 1M8451
For the administr Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.