510(k) K945494

WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS by Boston Scientific Scimed, Inc. — Product Code JCT

K945494 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS". The FDA issued a decision of Substantially Equivalent - Subject to Tracking Reg. on Mar 3, 1995. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Boston Scientific Scimed, Inc. has 34 other 510(k) clearances on record.