EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR

EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR is an FDA 510(k)-cleared medical device (K880052) manufactured by Baxter Healthcare Corp. This device is classified under the Cardiovascular specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 31, 1988. Regulation: 8.