BIVONA TRACHEAL T-TUBE STENT

BIVONA TRACHEAL T-TUBE STENT is an FDA 510(k)-cleared medical device (K920604) manufactured by Bivona Medical Technologies. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 1992. Regulation: 8.