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    K Number
    K042984
    Device Name
    INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
    Manufacturer
    INTERVASCULAR
    Date Cleared
    2005-02-18

    (112 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C

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

    The InterGard Woven Connector Graft is intended for use in arterial perfusion of the aorta, via femoral or axillary artery, for cardiopulmonary bypass when extracorporeal circulation is required for periods up to six (6.0) hours.

    Device Description

    InterGard Woven Connector Graft

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document appears to be an FDA 510(k) clearance letter for a medical device (InterGard Woven Connector Graft) and details its indications for use. However, it does not include any specifics about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or comparative effectiveness studies for the device.

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