OptiMap Catheter - 50mm (OPTI-CATH2-50)— 510(k) K253205

Substantially Equivalent

Cortex, Inc.

FDA 510(k) clearance K253205 for OptiMap Catheter - 50mm (OPTI-CATH2-50), Substantially Equivalent on 2026-03-13. Applicant: Cortex, Inc..

Clearance details

Applicant: Cortex, Inc.
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2025-09-26
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MTD

product code MTD

Death: 22
Injury: 376
Malfunction: 986
Total: 1,384

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.