510(k) K251928 ยท GEH Unit, Cryosurgical, Accessories
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
| Applicant | Medinice S.A., Warsaw, PL |
| Decision | Substantially Equivalent, Feb 13, 2026 |
| Received | Jun 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251928
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.