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510(k) Data Aggregation

    K Number
    K080679
    Device Name
    MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2008-06-27

    (109 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. Prior to commencing the delivery of food, confirmation of correct tube placement by acceptable hospital protocol is required.

    Device Description

    The CORTRAK™ System is an electrical device.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the CORTRAK™ System. It states that the device is substantially equivalent to a legally marketed predicate device. While it includes the intended use and regulatory information, it does not contain any details about acceptance criteria, specific device performance, or a study that proves the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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