
Mallinckrodt Medical
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SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA is an FDA 510(k)-cleared medical device (K051416) manufactured by Mallinckrodt Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2005. Regulation: 8.