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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 a medical device manufactured by Tianjin Medis Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2017-04-07 under approval 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. It is manufactured by Tianjin Medis Medical Device Co., Ltd.. The 510(k) number is K160694.

When was Disposable Endotracheal tube, sterile, AccuCuff approved by the FDA?

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

What company makes Disposable Endotracheal tube, sterile, AccuCuff?

Disposable Endotracheal tube, sterile, AccuCuff is manufactured by Tianjin Medis Medical Device Co., Ltd..

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 Devices by Tianjin Medis Medical Device Co., Ltd.

K190274Endotracheal Tube K182548Accucuff Cuff Pressure Indicator

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Official Source

View on FDA Database →

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

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