EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900

EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 is an FDA 510(k)-cleared medical device (K020864) 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 April 16, 2002. Regulation: 8.