OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION is an FDA 510(k)-cleared medical device (K063503) manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. 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 26, 2007. Regulation: 8.