Cleared Traditional

Tracheal Stent System (Y-Shaped)

K212403 · Micro-Tech (Nanjing) Co., Ltd. · Anesthesiology
Oct 2021
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K212403 is an FDA 510(k) clearance for the Tracheal Stent System (Y-Shaped), a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT), submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on October 30, 2021, 89 days after receiving the submission on August 2, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K212403 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2021
Decision Date October 30, 2021
Days to Decision 89 days
Submission Type Traditional
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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