510(k) K261012 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
OptiMap Catheter - 60mm (OPTI-CATH2-60)
| Applicant | Cortex, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Apr 23, 2026 |
| Received | Mar 27, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261012
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.