Cleared Traditional

CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY

K133597 · Cook, Inc. · Anesthesiology
Apr 2014
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K133597 is an FDA 510(k) clearance for the CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 18, 2014, 147 days after receiving the submission on November 22, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K133597 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2013
Decision Date April 18, 2014
Days to Decision 147 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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