510(k) K091582 ยท DQX Wire, Guide, Catheter
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
| Applicant | Medtronic Vascular, Danvers MA, US |
| Decision | Substantially Equivalent, Dec 4, 2009 |
| Received | Jun 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Medtronic Vascular ProVia CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS
Medtronic guide wires are steerable guide wires that are used for the introduct Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.