510(k) K160643 ยท DQX Wire, Guide, Catheter
ENROUTE 0.014 Guidewire
| Applicant | Lake Region Medical, Galway, IE |
| Decision | Substantially Equivalent, Oct 18, 2016 |
| Received | Mar 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160643
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.