510(k) K192525 ยท DQY Catheter, Percutaneous
087 Balloon Guide Catheter System
| Applicant | Q'Apel Medical, LLC, Santa Monica CA, US |
| Decision | Substantially Equivalent, Oct 31, 2019 |
| Received | Sep 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192525
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.