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    K Number
    DEN210024
    Device Name
    CavaClear Laser Sheath
    Manufacturer
    Spectranetics, Inc.
    Date Cleared
    2021-12-21

    (179 days)

    Product Code
    QRJ, ORJ
    Regulation Number
    870.5125
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the ablation of tissue in the removal of IVC filters that have failed a previous retrieval method.
    Device Description
    The CavaClear Laser Sheath is a 14Fr or 16 Fr laser sheath that transmits ultraviolet energy in (b)(4) pulse durations from Spectranetics' Excimer Laser generators to the tissue at the distal tip of the device. When the laser activates, a small amount of the tissue is ablated through photochemical, photothermal, and photomechanical interaction, vaporizing tissue overgrowth in order to allow for inferior vena cava (IVC) filter removal. The CavaClear Laser Sheath operates at repetition rates of 25-80Hz and fluence of 30-60mJ/mm2.
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