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FDA 510(k)

SILBRONCHO DOUBLE LUMEN TUBE

K-Number: K051522 · 2005-08-17

ApplicantFuji Systems Corp.
Decision Date2005-08-17
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SILBRONCHO DOUBLE LUMEN TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Systems Corp.. It received FDA 510(k) clearance on 2005-08-17 under 510(k) number K051522. 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 SILBRONCHO DOUBLE LUMEN TUBE?

SILBRONCHO DOUBLE LUMEN TUBE is a medical device that received FDA 510(k) clearance on 2005-08-17. The listed applicant is Fuji Systems Corp.. The 510(k) number is K051522.

When did SILBRONCHO DOUBLE LUMEN TUBE receive FDA 510(k) clearance?

SILBRONCHO DOUBLE LUMEN TUBE received FDA 510(k) clearance on 2005-08-17, under 510(k) number K051522.

Who is the listed applicant for SILBRONCHO DOUBLE LUMEN TUBE?

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

What is the FDA product code for SILBRONCHO DOUBLE LUMEN TUBE?

The FDA product code for SILBRONCHO DOUBLE LUMEN TUBE is CBI.

Related Clinical Trials

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Other records listing Fuji Systems Corp. as applicant

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.

K120781CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH

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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