510(k) K260437 ยท OZT Balloon Aortic Valvuloplasty
Valvuloplasty Balloon Catheter (ValvuloPro)
| Applicant | Dongguan TT Medical, Inc., Dongguan, CN |
| Decision | Substantially Equivalent, Mar 20, 2026 |
| Received | Feb 11, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260437
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.