BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE

BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE is an FDA 510(k)-cleared medical device (K931735) 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 May 17, 1993. Regulation: 8.