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510(k) Data Aggregation

    K Number
    K153502
    Device Name
    ClariVein IC
    Manufacturer
    VASCULAR INSIGHTS, LLC
    Date Cleared
    2016-01-06

    (30 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR INSIGHTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clari Vein IC is indicated for infusion of physician specified agents in the peripheral vasculature.
    Device Description
    The ClariVein IC is a specialty infusion catheter with 360°rotatable fluid dispersion wire connected to a proximally located integral battery powered motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features which facilitate physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The Clari Vein IC has no user serviceable parts or capital equipment. It is provided to the user sterile, for single patient use and is fully disposable.
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