DETLOGIX ANNULOPLASTY RING, MODEL: 5100

DETLOGIX ANNULOPLASTY RING, MODEL: 5100 is an FDA 510(k)-cleared medical device (K083191) 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 9, 2009. Regulation: 8.