Cleared Traditional

SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF

K971267 · Mallinckrodt Medical · Anesthesiology
Sep 1997
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K971267 is an FDA 510(k) clearance for the SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on September 25, 1997, 174 days after receiving the submission on April 4, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K971267 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1997
Decision Date September 25, 1997
Days to Decision 174 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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