510(k) K161287 ยท DQO Catheter, Intravascular, Diagnostic
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
| Applicant | Medtronic Vascular, Danvers MA, US |
| Decision | Unknown, Aug 19, 2016 |
| Received | May 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161287
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2018 | Medtronic Vascular Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 Terminated |
DQO | None listed |
| Apr 20, 2018 | Medtronic Vascular Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.