ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR

ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR is an FDA 510(k)-cleared medical device (K083835) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2009. Regulation: 8.