About This 510(k) Submission
K152842 is an FDA 510(k) clearance for the WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL, a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT), submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on May 19, 2016, 233 days after receiving the submission on September 29, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3720.