Portex Blue Line Ultra Paediatric Tracheosomy Tube

Portex Blue Line Ultra Paediatric Tracheosomy Tube is an FDA 510(k)-cleared medical device (K170720) manufactured by Smiths Medical Asd, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2017. Regulation: 8.