510(k) K231814 ยท OZT Balloon Aortic Valvuloplasty
ValvuloPro Valvuloplasty Balloon Catheter
| Applicant | Dongguan TT Medical, Inc., Dongguan, CN |
| Decision | Substantially Equivalent, Oct 12, 2023 |
| Received | Jun 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231814
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.