FDA 510(k)

Wei Nasal Jet Tube

K-Number: K211543 · 2022-07-21

Decision Date2022-07-21

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Wei Nasal Jet Tube is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-21 under approval number K211543. 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 Wei Nasal Jet Tube?

Wei Nasal Jet Tube is a medical device that received FDA 510(k) clearance on 2022-07-21. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K211543.

When was Wei Nasal Jet Tube approved by the FDA?

Wei Nasal Jet Tube received FDA 510(k) clearance on 2022-07-21, under approval number K211543.

What company makes Wei Nasal Jet Tube?

Wei Nasal Jet Tube is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Wei Nasal Jet Tube?

The FDA product code for Wei Nasal Jet Tube is BTR.

Other Devices by Well Lead Medical Co., Ltd.

K160801Well Lead Extraction Bag K161110ClearPetra Suction-Evacuation Sheath K151084Well Lead Ureteral Access Sheath K162340Stomach Tube K182739Endotracheal Tube with Evacuation Lumen K203119ClearPetra Suction-Evacuation Sheath

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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.