COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR

COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR is an FDA 510(k)-cleared medical device (K133600) manufactured by Coeur, 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 29, 2014. Regulation: 8.