CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING is an FDA 510(k)-cleared medical device (K103520) manufactured by Edwards Lifesciences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2011. Regulation: 8.