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    K Number
    K992942
    Device Name
    LEMAITRE OCCLUSION CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-04-13

    (226 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LEMAITRE OCCLUSION CATHETER

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

    The LeMaitre Occlusion Catheter is indicated for temporary vessel occlusion.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document contains a letter from the FDA to a medical device manufacturer concerning the clearance of a "LeMaitre Occlusion Catheter." It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, study designs (MRMC, standalone), or ground truth establishment relevant to an AI/ML device.

    Therefore, I cannot provide the requested information based on the provided text.

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