
Cook, Inc.
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CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER is an FDA 510(k)-cleared medical device (K072148) manufactured by Cook, 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 October 2, 2007. Regulation: 8.