510(k) K121048

ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED by Boston Scientific Corp — Product Code JCT

K121048 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED". The FDA issued a decision of Substantially Equivalent on August 3, 2012. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Boston Scientific Corp has at least 10 other 510(k) clearances on record.