RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED

RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED is an FDA 510(k)-cleared medical device (K021764) manufactured by Rusch Intl.. 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 22, 2002. Regulation: 8.