LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)

LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) is an FDA 510(k)-cleared medical device (K873461) manufactured by Mallinckrodt Critical Care. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 1987. Regulation: 8.