RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE

RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE is an FDA 510(k)-cleared medical device (K964056) 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 October 9, 1997. Regulation: 8.