LUMEND FRONTRUNNER CTO CORONARY CATHETER

LUMEND FRONTRUNNER CTO CORONARY CATHETER is an FDA 510(k)-cleared medical device (K013284) manufactured by Lumend, 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 February 10, 2002. Regulation: 8.