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FDA 510(k)

Disposable Endotracheal tube, sterile, AccuCuff

K-Number: K160694 · 2017-04-07

ApplicantTianjin Medis Medical Device Co., Ltd.
Decision Date2017-04-07
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Disposable Endotracheal tube, sterile, AccuCuff 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 2017-04-07 under 510(k) number K160694. 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 Disposable Endotracheal tube, sterile, AccuCuff?

Disposable Endotracheal tube, sterile, AccuCuff is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. The 510(k) number is K160694.

When did Disposable Endotracheal tube, sterile, AccuCuff receive FDA 510(k) clearance?

Disposable Endotracheal tube, sterile, AccuCuff received FDA 510(k) clearance on 2017-04-07, under 510(k) number K160694.

Who is the listed applicant for Disposable Endotracheal tube, sterile, AccuCuff?

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 Disposable Endotracheal tube, sterile, AccuCuff?

The FDA product code for Disposable Endotracheal tube, sterile, AccuCuff is BTR.

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.

K190274Endotracheal TubeK182548Accucuff Cuff Pressure Indicator

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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