BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES

BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES is an FDA 510(k)-cleared medical device (K944178) 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 October 26, 1994. Regulation: 8.