Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is an FDA 510(k)-cleared medical device (K193077) manufactured by Covidien. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2020. Regulation: 8.