510(k) K152842

WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL by Boston Scientific Corporation — Product Code JCT

K152842 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL". The FDA issued a decision of Substantially Equivalent on May 19, 2016. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2016
Date Received
September 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type