RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE

RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE is an FDA 510(k)-cleared medical device (K955564) manufactured by Rusch, Inc.. 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 27, 1996. Regulation: 8.