Cleared Traditional

VORTRAN Cuff Inflator (VCI)

K173914 · Vortran Medical Technology 1, Inc. · Anesthesiology
May 2018
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K173914 is an FDA 510(k) clearance for the VORTRAN Cuff Inflator (VCI), a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on May 25, 2018, 154 days after receiving the submission on December 22, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K173914 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2017
Decision Date May 25, 2018
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750