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FDA 510(k)

Endotracheal Tube with Evacuation Lumen

K-Number: K182739 · 2019-12-11

ApplicantWell Lead Medical Co., Ltd.
Decision Date2019-12-11
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Endotracheal Tube with Evacuation Lumen is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-12-11 under approval number K182739. 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 with Evacuation Lumen?

Endotracheal Tube with Evacuation Lumen is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K182739.

When was Endotracheal Tube with Evacuation Lumen approved by the FDA?

Endotracheal Tube with Evacuation Lumen received FDA 510(k) clearance on 2019-12-11, under approval number K182739.

What company makes Endotracheal Tube with Evacuation Lumen?

Endotracheal Tube with Evacuation Lumen is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Endotracheal Tube with Evacuation Lumen?

The FDA product code for Endotracheal Tube with Evacuation Lumen is BTR.

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING

Other Devices by Well Lead Medical Co., Ltd.

K160801Well Lead Extraction Bag K161110ClearPetra Suction-Evacuation Sheath K151084Well Lead Ureteral Access Sheath K162340Stomach Tube K203119ClearPetra Suction-Evacuation Sheath K202134Well Lead All Silicone Foley Catheter with Temperature Sensor

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Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K181880VivaSight-SL (TVT) systemEtview , Ltd. K171917Frova Intubating IntroducerCook Incorporated K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.

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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