HEPARIN COATED BALLOON THERMODILU

HEPARIN COATED BALLOON THERMODILU is an FDA 510(k)-cleared medical device (K834037) manufactured by Nova Medical Specialties. 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 9, 1984. Regulation: 8.