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510(k) Data Aggregation

    K Number
    K980723
    Device Name
    2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    1999-02-12

    (353 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)

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

    Cuts saphenous vein valves during in situ bypass procedure in lower extremities.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer any of the questions regarding acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a medical device (2.0mm Expandable Lemaitre Valvulotome), which only confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

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