FDA Product Code BTR: Tube, Tracheal (w/wo Connector)
FDA product code BTR covers tracheal tubes used to maintain an open airway during anesthesia, mechanical ventilation, and emergency airway management.
These tubes are inserted through the mouth or nose into the trachea to provide a secure, controlled airway that prevents aspiration and enables mechanical ventilation. They are available with or without inflatable cuffs, in a range of sizes for adults and children.
BTR devices are Class II medical devices, regulated under 21 CFR 868.5730 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Covidien, LLC, Covidien and Teleflex Medical.
List of Tube, Tracheal (w/wo Connector) devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Tube, Tracheal (w/wo Connector) devices (product code BTR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →