510(k) K241562 ยท OZT Balloon Aortic Valvuloplasty
OutFlo Aortic Valve Dilatation Balloon Catheter
| Applicant | Disa Medinotec, Johannesburg, ZA |
| Decision | Substantially Equivalent, Mar 11, 2025 |
| Received | May 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241562
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.