ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 is an FDA 510(k)-cleared medical device (K023185) 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 December 16, 2002. Regulation: 8.