CG FUTURE ANNULOPLASTY BAND

CG FUTURE ANNULOPLASTY BAND is an FDA 510(k)-cleared medical device (K052860) manufactured by Medtronic Heart Valves. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 9, 2005. Regulation: 8.