PROSTHETIC RINGS #4400 MITRAL & 4500

PROSTHETIC RINGS #4400 MITRAL & 4500 is an FDA 510(k)-cleared medical device (K831949) manufactured by American Edwards Laboratories. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 1983. Regulation: 8.