FDA 510(k)

Endotracheal tube; Reinforced Endotracheal tube

N.º K: K170234 · 2018-01-17

SolicitanteZhanjiang Star Enterprise Co., Ltd.

Fecha de decisión2018-01-17

Código de productoBTR

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Endotracheal tube; Reinforced Endotracheal tube is the device name listed in this FDA 510(k) record. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K170234. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Endotracheal tube; Reinforced Endotracheal tube?

Endotracheal tube; Reinforced Endotracheal tube is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. The 510(k) number is K170234.

When did Endotracheal tube; Reinforced Endotracheal tube receive FDA 510(k) clearance?

Endotracheal tube; Reinforced Endotracheal tube received FDA 510(k) clearance on 2018-01-17, under 510(k) number K170234.

Who is the listed applicant for Endotracheal tube; Reinforced Endotracheal tube?

The FDA 510(k) record lists Zhanjiang Star Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endotracheal tube; Reinforced Endotracheal tube?

The FDA product code for Endotracheal tube; Reinforced Endotracheal tube is BTR.

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Dispositivos relacionados (Código: BTR)

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro Robotics K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLC K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLC K243579Catheter de Ventilación AeroJetPipeline Medical Products, LLC K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps

Fuente oficial

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