Cleared Special

Ultraflex? Tracheobronchial Stent System

K230269 · Boston Scientific Corporation · Anesthesiology
Jul 2023
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K230269 is an FDA 510(k) clearance for the Ultraflex? Tracheobronchial Stent System, a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on July 14, 2023, 164 days after receiving the submission on January 31, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K230269 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2023
Decision Date July 14, 2023
Days to Decision 164 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JCT — Prosthesis, Tracheal, Expandable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3720

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