ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED

ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED is an FDA 510(k)-cleared medical device (K121048) manufactured by Boston Scientific Corp. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2012. Regulation: 8.