PERCUTANEOUS TRACHEOSTOMY KIT

PERCUTANEOUS TRACHEOSTOMY KIT is an FDA 510(k)-cleared medical device (K936133) 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 March 22, 1994. Regulation: 8.