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FDA 510(k)

Endotracheal tube; Reinforced Endotracheal tube

K-Number: K170234 · 2018-01-17

ApplicantZhanjiang Star Enterprise Co., Ltd.
Decision Date2018-01-17
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Endotracheal tube; Reinforced Endotracheal tube is a medical device manufactured by Zhanjiang Star Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-01-17 under approval number K170234. 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; Reinforced Endotracheal tube?

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

When was Endotracheal tube; Reinforced Endotracheal tube approved by the FDA?

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

What company makes Endotracheal tube; Reinforced Endotracheal tube?

Endotracheal tube; Reinforced Endotracheal tube is manufactured by Zhanjiang Star Enterprise Co., Ltd..

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

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

Other Devices by Zhanjiang Star Enterprise Co., Ltd.

K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

Related Devices (Code: BTR)

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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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