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The devices are indicated for airway management in patients, during surgical procedures involving the head, neck, or mouth, to provide a clear surgical field by directing the circuit and connectors away from the operative area and reduce the risk of kink.

The subject device of this premarket 510(k) notification is referred to as Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye. The Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye has a translucent polyvinyl chloride (PVC) tube shaft with a radiopaque filament along its length. The subject device is offered as cuffless or cuffed in various sizes, for either oral or nasal use. All tubes are single use, sterilized by ethylene oxide, and supplied with a standard 15mm connector. The subject device and its packaging are not made with rubber latex or DEHP.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, and number of murphy eyes.

a) Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye
b) Shiley™ Nasal RAE Tracheal Tube Cuffless Murphy Eye
c) Shiley™ Oral RAE Tracheal Tube Cuffed Murphy Eye
d) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye
e) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye

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