BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE

BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K912469) 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 June 18, 1991. Regulation: 8.