FDA 510(k)

Wei Nasal Jet Tube

N.º K: K211543 · 2022-07-21

Fecha de decisión2022-07-21

Código de productoBTR

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Wei Nasal Jet Tube is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K211543. 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 Wei Nasal Jet Tube?

Wei Nasal Jet Tube is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K211543.

When did Wei Nasal Jet Tube receive FDA 510(k) clearance?

Wei Nasal Jet Tube received FDA 510(k) clearance on 2022-07-21, under 510(k) number K211543.

Who is the listed applicant for Wei Nasal Jet Tube?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wei Nasal Jet Tube?

The FDA product code for Wei Nasal Jet Tube is BTR.

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Otros registros que enlistan a Well Lead Medical Co., Ltd. como solicitante

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact K220722PVC Hydrophilic Urethral Catheter K220036Wellead Ureteral Catheter K211814Wellead Endoscopic Seal K202134Well Lead All Silicone Foley Catheter with Temperature Sensor K203119ClearPetra Suction-Evacuation Sheath

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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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