510(k) K221390 ยท DQX Wire, Guide, Catheter
BNLE Access Guidewire
| Applicant | Biomerics Nle, Brooklyn Park MN, US |
| Decision | Substantially Equivalent, Apr 28, 2023 |
| Received | May 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221390
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.