Cleared Traditional

HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES

K965132 · Mallinckrodt Medical · Anesthesiology
Mar 1997
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K965132 is an FDA 510(k) clearance for the HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on March 20, 1997, 87 days after receiving the submission on December 23, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K965132 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1996
Decision Date March 20, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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