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FDA 510(k)

5.0 Fr Arndt Endobronchial Blocker Set

K-Number: K160542 · 2016-08-02

ApplicantCook Incorporated
Decision Date2016-08-02
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

5.0 Fr Arndt Endobronchial Blocker Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K160542. 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 5.0 Fr Arndt Endobronchial Blocker Set?

5.0 Fr Arndt Endobronchial Blocker Set is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Cook Incorporated. The 510(k) number is K160542.

When did 5.0 Fr Arndt Endobronchial Blocker Set receive FDA 510(k) clearance?

5.0 Fr Arndt Endobronchial Blocker Set received FDA 510(k) clearance on 2016-08-02, under 510(k) number K160542.

Who is the listed applicant for 5.0 Fr Arndt Endobronchial Blocker Set?

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

What is the FDA product code for 5.0 Fr Arndt Endobronchial Blocker Set?

The FDA product code for 5.0 Fr Arndt Endobronchial Blocker Set 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

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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