510(k) K253205 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
OptiMap Catheter - 50mm (OPTI-CATH2-50)
| Applicant | Cortex, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253205
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.