Cleared Special

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA

K051416 · Mallinckrodt Medical · Anesthesiology
Jun 2005
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K051416 is an FDA 510(k) clearance for the SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Mallinckrodt Medical (Pleasanton, US). The FDA issued a Cleared decision on June 16, 2005, 15 days after receiving the submission on June 1, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K051416 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2005
Decision Date June 16, 2005
Days to Decision 15 days
Submission Type Special
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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