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FDA 510(k)

RUSCH ENDOBRONCHIAL TUBE SETS

K-Number: K951091 · 1995-06-08

ApplicantRusch Intl.
Decision Date1995-06-08
Product CodeBTS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH ENDOBRONCHIAL TUBE SETS is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 1995-06-08 under 510(k) number K951091. The device is classified under product code BTS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH ENDOBRONCHIAL TUBE SETS?

RUSCH ENDOBRONCHIAL TUBE SETS is a medical device that received FDA 510(k) clearance on 1995-06-08. The listed applicant is Rusch Intl.. The 510(k) number is K951091.

When did RUSCH ENDOBRONCHIAL TUBE SETS receive FDA 510(k) clearance?

RUSCH ENDOBRONCHIAL TUBE SETS received FDA 510(k) clearance on 1995-06-08, under 510(k) number K951091.

Who is the listed applicant for RUSCH ENDOBRONCHIAL TUBE SETS?

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 ENDOBRONCHIAL TUBE SETS?

The FDA product code for RUSCH ENDOBRONCHIAL TUBE SETS is BTS.

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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

View all 43 devices →

Related Devices (Code: BTS)

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.

K953963RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATIONRusch, Inc.K902116MODIFIED ENDOBRONCHIAL TUBEConcord/PortexK834565ENDOBRONCHIAL TWIN LUMEN TUBEPortex, Inc.K833297BRONCHOSCOPY TUBE W/ULTRA LOCUFFSurgitekK771219BRONCHO-CATHMallinckrodt Critical Care

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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