Edwards MC3 Tricuspid annuloplasty ring (4900)

Edwards MC3 Tricuspid annuloplasty ring (4900) is an FDA 510(k)-cleared medical device (K251982) 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 September 22, 2025. Regulation: 8.