OptiMap Catheter - 60mm (OPTI-CATH2-60)

OptiMap Catheter - 60mm (OPTI-CATH2-60) is an FDA 510(k)-cleared medical device (K261012) 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 April 22, 2026. Regulation: 8.