510(k) K180395 ยท FMI Needle, Hypodermic, Single Lumen
EZ-IO Intraosseous Vascular Access System
| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Nov 9, 2018 |
| Received | Feb 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180395
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.