OptiMap Catheter - 50mm (OPTI-CATH2-50)

OptiMap Catheter - 50mm (OPTI-CATH2-50) is an FDA 510(k)-cleared medical device (K253205) manufactured by Cortex, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2026. Regulation: 8.