Cleared Traditional

AEROmini Tracheobronchial Stent System

K181200 · Merit Medical Systems, Inc. · Anesthesiology
Sep 2018
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K181200 is an FDA 510(k) clearance for the AEROmini Tracheobronchial Stent System, a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 21, 2018, 137 days after receiving the submission on May 7, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K181200 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2018
Decision Date September 21, 2018
Days to Decision 137 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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