K253205
- 510(k) number
- K253205
- Device name
- OptiMap Catheter - 50mm (OPTI-CATH2-50)
- Applicant
- Cortex, Inc. CA · US
- Product code
- MTD — Catheter, Intracardiac Mapping, High-Density Array
- Decision date
- 2026-03-13
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253205.pdf
Official FDA record: K253205
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.