STAT-TRACH(TM) VENTILATION CATHETER

STAT-TRACH(TM) VENTILATION CATHETER is an FDA 510(k)-cleared medical device (K894096) manufactured by Statron Corp.. 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 15, 1990. Regulation: 8.