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FDA 510(k)

Endotracheal Tube

K-Number: K190274 · 2019-07-30

ApplicantTianjin Medis Medical Device Co., Ltd.
Decision Date2019-07-30
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Endotracheal Tube is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K190274. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endotracheal Tube?

Endotracheal Tube is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. The 510(k) number is K190274.

When did Endotracheal Tube receive FDA 510(k) clearance?

Endotracheal Tube received FDA 510(k) clearance on 2019-07-30, under 510(k) number K190274.

Who is the listed applicant for Endotracheal Tube?

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

What is the FDA product code for Endotracheal Tube?

The FDA product code for Endotracheal Tube is BTR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02708836Limiting Emergence Phenomena After General Anesthesia With Combined LMA and ETT Airway Management TechniqueRECRUITINGNCT03812718Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask AirwayRECRUITINGNCT04079387Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube AloneCOMPLETEDNCT04498598Structural Modification In Supraglottic Airway DeviceRECRUITINGNCT05525702VR Interventions to Reduce the Prevalence of Delirium in ICU PatientsRECRUITINGNCT05632107Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® MonitorRECRUITING

Other records listing Tianjin Medis Medical Device Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182548Accucuff Cuff Pressure IndicatorK160694Disposable Endotracheal tube, sterile, AccuCuff

Related Devices (Code: BTR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253437Spiro-VISTASpiro RoboticsK250173Shiley™ 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, LLCK243785Shiley™ 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, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova 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 ApsK250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)Flexicare Medical Limited.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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