510(k) K980163

WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING by Boston Scientific Scimed, Inc. — Product Code JCT

K980163 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING". The FDA issued a decision of Substantially Equivalent on Mar 13, 1998. 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.