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FDA 510(k)

ENDOBRONCHIAL TWIN LUMEN TUBE

K-Number: K834565 · 1984-01-17

ApplicantPortex, Inc.
Decision Date1984-01-17
Product CodeBTS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENDOBRONCHIAL TWIN LUMEN TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 1984-01-17 under 510(k) number K834565. 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 ENDOBRONCHIAL TWIN LUMEN TUBE?

ENDOBRONCHIAL TWIN LUMEN TUBE is a medical device that received FDA 510(k) clearance on 1984-01-17. The listed applicant is Portex, Inc.. The 510(k) number is K834565.

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

ENDOBRONCHIAL TWIN LUMEN TUBE received FDA 510(k) clearance on 1984-01-17, under 510(k) number K834565.

Who is the listed applicant for ENDOBRONCHIAL TWIN LUMEN TUBE?

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

What is the FDA product code for ENDOBRONCHIAL TWIN LUMEN TUBE?

The FDA product code for ENDOBRONCHIAL TWIN LUMEN TUBE is BTS.

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Other records listing Portex, Inc. 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.

K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERK031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITK0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORK0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXK014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICEK873992LARYNGECTOMY TUBE

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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.K902116MODIFIED ENDOBRONCHIAL TUBEConcord/PortexK833297BRONCHOSCOPY 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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