CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS

CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS is an FDA 510(k)-cleared medical device (K914972) manufactured by Baxter Healthcare Corp. 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 8, 1992. Regulation: 8.