510(k) K141584

ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM by Boston Scientific Corporation — Product Code JCT

K141584 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 2014. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.