MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE is an FDA 510(k)-cleared medical device (K980016) manufactured by Genzyme Surgical Product (Genzyme Biosurgery). This device is classified under the Cardiovascular specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 6, 1998. Regulation: 8.