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FDA 510(k)

WELL LEAD ENDOBRONCHIAL TUBES

K-Number: K092886 · 2010-03-11

ApplicantWell Lead Instruments
Decision Date2010-03-11
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WELL LEAD ENDOBRONCHIAL TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Instruments. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K092886. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELL LEAD ENDOBRONCHIAL TUBES?

WELL LEAD ENDOBRONCHIAL TUBES is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Well Lead Instruments. The 510(k) number is K092886.

When did WELL LEAD ENDOBRONCHIAL TUBES receive FDA 510(k) clearance?

WELL LEAD ENDOBRONCHIAL TUBES received FDA 510(k) clearance on 2010-03-11, under 510(k) number K092886.

Who is the listed applicant for WELL LEAD ENDOBRONCHIAL TUBES?

The FDA 510(k) record lists Well Lead Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELL LEAD ENDOBRONCHIAL TUBES?

The FDA product code for WELL LEAD ENDOBRONCHIAL TUBES is CBI.

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Related Devices (Code: CBI)

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.

K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)Hangzhou Tappa Medical Technology Co., Ltd.K253096Chartis Precision CatheterPulmonx CorporationK232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd.K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.K222340Chartis Precision CatheterPulmonx CorporationK201026sOLVe TubeHytek Medical, Inc.

Official Source

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

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