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510(k) Data Aggregation

    K Number
    K013577
    Device Name
    ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2002-01-25

    (88 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ultramax™ Woven Velour Vascular Graft is indicated for surgical repair, bypass or replacement of damaged vessels of the abdomen in cases of aneurysmal or occlusive disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Ultramax™ Woven Velour Vascular Graft. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

    This letter is a regulatory document stating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It refers to the "indications for use stated in the enclosure" and general controls provisions but does not elaborate on the specific technical performance or clinical study details that would typically be contained within the 510(k) submission itself.

    Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.

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