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FDA 510(k)

MODIFIED ENDOBRONCHIAL TUBE

K-Number: K902116 · 1990-08-03

ApplicantConcord/Portex
Decision Date1990-08-03
Product CodeBTS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED ENDOBRONCHIAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1990-08-03 under 510(k) number K902116. 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 MODIFIED ENDOBRONCHIAL TUBE?

MODIFIED ENDOBRONCHIAL TUBE is a medical device that received FDA 510(k) clearance on 1990-08-03. The listed applicant is Concord/Portex. The 510(k) number is K902116.

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

MODIFIED ENDOBRONCHIAL TUBE received FDA 510(k) clearance on 1990-08-03, under 510(k) number K902116.

Who is the listed applicant for MODIFIED ENDOBRONCHIAL TUBE?

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

What is the FDA product code for MODIFIED ENDOBRONCHIAL TUBE?

The FDA product code for MODIFIED ENDOBRONCHIAL TUBE is BTS.

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Other records listing Concord/Portex 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.

K923559STERI-CATH MDIK930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESK924541EPIDURAL MINIPACKK930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSK923127NEEDLE-PRO CARTRIDGEK923910HEAT MOISTURE CONDENSER

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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.K951091RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl.K834565ENDOBRONCHIAL 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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