SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR is an FDA 510(k)-cleared medical device (K974648) manufactured by Sulzer Carbomedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 3, 1998. Regulation: 8.