510(k) K050832

FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT by Bard Peripheral Vascular, Inc. — Product Code JCT

K050832 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT". The FDA issued a decision of Substantially Equivalent on July 7, 2005. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.