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510(k) Data Aggregation

    K Number
    K071468
    Device Name
    CLARIVEIN CATHETER
    Manufacturer
    VASCULAR INSIGHTS LLC
    Date Cleared
    2008-03-20

    (296 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 ClariVein™ Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature.
    Device Description
    The ClariVein™ Infusion Catheter (ClariVein™-IC) is an infusion catheter system designed to introduce physician-specified medicaments into the peripheral vasculature. Infusion is through an opening at the distal end of the catheter and fluid delivery is enhanced by the use of a rotating dispersion wire to mix and disperse the infused fluid in the blood stream and on the vessel wall. The dispersion wire, connected to an interface cartridge for proximal connection to the motorized handle, extends through the catheter lumen. Prior to drug infusion the catheter sheath is inserted into the vasculature and once the catheter tip is positioned at the treatment site, the catheter sheath is retracted to expose the dispersion wire tip. Wire rotation is controlled by a 9V DC motorized Handle Unit. The Handle Unit also provides a grip and syringe holder to facilitate physiciancontrolled infusion.
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