510(k) K141117 ยท FMI Needle, Hypodermic, Single Lumen
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
| Applicant | Vidacare, LLC, Shavano Park TX, US |
| Decision | Substantially Equivalent, Jul 8, 2014 |
| Received | Apr 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2019 | Teleflex Medical Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access Open, Classified |
FMI | None listed |
| Oct 8, 2019 | Teleflex Medical Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access Open, Classified |
FMI | None listed |
| Oct 8, 2019 | Teleflex Medical Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.