REFLEXION HD HIGH-DENSITY MAPPING CATHETER

REFLEXION HD HIGH-DENSITY MAPPING CATHETER is an FDA 510(k)-cleared medical device (K080179) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2009. Regulation: 8.