CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE

CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE is an FDA 510(k)-cleared medical device (K942736) manufactured by Carbomedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 5, 1994. Regulation: 8.