510(k) K180588 · FMI Needle, Hypodermic, Single Lumen
FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device
| Applicant | Teleflex Medical, Morrisville NC, US |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Mar 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180588
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.