ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI

ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI is an FDA 510(k)-cleared medical device (K912554) 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 September 8, 1991. Regulation: 8.