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FDA 510(k)

ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER

K-Number: K002288 · 2000-11-28

ApplicantCook, Inc.
Decision Date2000-11-28
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2000-11-28 under 510(k) number K002288. 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 ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER?

ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER is a medical device that received FDA 510(k) clearance on 2000-11-28. The listed applicant is Cook, Inc.. The 510(k) number is K002288.

When did ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER receive FDA 510(k) clearance?

ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER received FDA 510(k) clearance on 2000-11-28, under 510(k) number K002288.

Who is the listed applicant for ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER?

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

What is the FDA product code for ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER?

The FDA product code for ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER is CBI.

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Other records listing Cook, Inc. as applicant

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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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