Cleared Traditional

ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET

K013241 · Cook, Inc. · Anesthesiology
Feb 2002
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K013241 is an FDA 510(k) clearance for the ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET, a Needle, Emergency Airway (Class II — Special Controls, product code BWC), submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on February 21, 2002, 146 days after receiving the submission on September 28, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5090.

Submission Details

510(k) Number K013241 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2001
Decision Date February 21, 2002
Days to Decision 146 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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