510(k) K253855 ยท OZT Balloon Aortic Valvuloplasty
KardiaPSI Balloon Catheter
| Applicant | Intervention Tech, Inc. ; dba Corvention, Flagstaff AZ, US |
| Decision | Substantially Equivalent, May 6, 2026 |
| Received | Dec 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253855
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.