COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 is an FDA 510(k)-cleared medical device (K923367) 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 5, 1993. Regulation: 8.