510(k) K091140 ยท FMI Needle, Hypodermic, Single Lumen
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
| Applicant | Vidacare Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 14, 2009 |
| Received | Apr 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091140
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2017 | Teleflex Medical Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.