510(k) K253746 ยท DQX Wire, Guide, Catheter
Enroute 0.014'' Transcarotid Guidewire
| Applicant | Lake Region Medical, Galway, IE |
| Decision | Substantially Equivalent, Mar 19, 2026 |
| Received | Nov 25, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253746
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.