PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K962175) manufactured by Smiths Industries Medical Systems, 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 January 16, 1997. Regulation: 8.