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    K Number
    K090084
    Device Name
    ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Date Cleared
    2009-03-06

    (53 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K070378,K051287
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for use with an appropriate laser for vein ablation procedures.
    The ELAtionTM Endovenous Laser Procedure Kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein and for treatment of incompetence and reflux of superficial veins in the lower extremity. The kit is intended to be used with an 810 nm, 940 nm, or 980 nm laser.

    Device Description

    Not Found

    AI/ML Overview

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