Cleared Special

SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES

K082520 · Mallinckrodt Medical · Anesthesiology
Oct 2008
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K082520 is an FDA 510(k) clearance for the SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Mallinckrodt Medical (Boulder, US). The FDA issued a Cleared decision on October 2, 2008, 30 days after receiving the submission on September 2, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K082520 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2008
Decision Date October 02, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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