510(k) K120661 ยท FMI Needle, Hypodermic, Single Lumen
THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
| Applicant | Vidacare Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 3, 2012 |
| Received | Mar 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2015 | Vidacare Corporation T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.