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FDA 510(k)

RUSCH BRONCHUS BLOCKER KIT

K-Number: K010596 · 2001-11-21

ApplicantRusch Intl.
Decision Date2001-11-21
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH BRONCHUS BLOCKER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 2001-11-21 under 510(k) number K010596. 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 RUSCH BRONCHUS BLOCKER KIT?

RUSCH BRONCHUS BLOCKER KIT is a medical device that received FDA 510(k) clearance on 2001-11-21. The listed applicant is Rusch Intl.. The 510(k) number is K010596.

When did RUSCH BRONCHUS BLOCKER KIT receive FDA 510(k) clearance?

RUSCH BRONCHUS BLOCKER KIT received FDA 510(k) clearance on 2001-11-21, under 510(k) number K010596.

Who is the listed applicant for RUSCH BRONCHUS BLOCKER KIT?

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

What is the FDA product code for RUSCH BRONCHUS BLOCKER KIT?

The FDA product code for RUSCH BRONCHUS BLOCKER KIT is CBI.

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Other records listing Rusch Intl. 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.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR TUBE

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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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