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    K Number
    K032204
    Device Name
    MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Date Cleared
    2003-08-20

    (33 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K000737
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

    Device Description

    The VARI-LASE procedure kit contains a 600µm fiber and may contain one ore more of the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150cm) 5Fr/25 or 45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture Kit

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device. It does not describe an AI/ML device, nor does it contain information about acceptance criteria, study performance, or ground truth as requested in the prompt.

    Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical medical device (a laser procedure kit for treating varicose veins) and details its substantial equivalence to a previously marketed device, not the performance of an AI model.

    The sections for AI/ML device evaluation within your prompt (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to the content of this document.

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