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FDA 510(k)

RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED

K-Number: K021764 · 2002-07-23

ApplicantRusch Intl.
Decision Date2002-07-23
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 2002-07-23 under 510(k) number K021764. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED?

RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED is a medical device that received FDA 510(k) clearance on 2002-07-23. The listed applicant is Rusch Intl.. The 510(k) number is K021764.

When did RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED receive FDA 510(k) clearance?

RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED received FDA 510(k) clearance on 2002-07-23, under 510(k) number K021764.

Who is the listed applicant for RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED?

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 TRACHEOFIX SET, CUFFED AND UNCUFFED?

The FDA product code for RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED is BTO.

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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: BTO)

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.

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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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