TRACHEOSTOMY TUBE AND CUFF

TRACHEOSTOMY TUBE AND CUFF is an FDA 510(k)-cleared medical device (K912124) manufactured by Concord/Portex. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 15, 1991. Regulation: 8.