Cleared Traditional

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE

K093135 · Venner Medical (Singapore) Pte, Ltd. · Anesthesiology
Apr 2010
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K093135 is an FDA 510(k) clearance for the VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Venner Medical (Singapore) Pte, Ltd. (Dallas, US). The FDA issued a Cleared decision on April 2, 2010, 179 days after receiving the submission on October 5, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K093135 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2009
Decision Date April 02, 2010
Days to Decision 179 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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