Cleared Traditional

Emergency Transtracheal Airway Catheter

K153761 · Cook Incorporated · Anesthesiology
Sep 2016
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K153761 is an FDA 510(k) clearance for the Emergency Transtracheal Airway Catheter, a Needle, Emergency Airway (Class II — Special Controls, product code BWC), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 22, 2016, 267 days after receiving the submission on December 30, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5090.

Submission Details

510(k) Number K153761 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2015
Decision Date September 22, 2016
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWC — Needle, Emergency Airway
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5090

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