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510(k) Data Aggregation

    K Number
    K971966
    Device Name
    CORONARY VEIN GRAFT TAG MARKER
    Manufacturer
    MED-EDGE, INC.
    Date Cleared
    1998-01-26

    (243 days)

    Product Code
    KPK
    Regulation Number
    878.4650
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-EDGE, INC.

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

    A radiopaque marker used to identify the coronary vein graft which is commonly used to revascularize the blood supply to the heart. The marker is attached to the distal and / or proximal anastomosis sites of the graft by the surgeon during the CABG procedure. The marker can subsequently be used by the cardiologist during cardiac catheterization as a landmark to easily identify the anastomosis site of the vein graft utilizing fluoroscopy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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