ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 is an FDA 510(k)-cleared medical device (K992056) manufactured by Sulzer Carbomedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 1999. Regulation: 8.