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    K Number
    K023023
    Device Name
    LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
    Manufacturer
    VASCA, INC.
    Date Cleared
    2003-12-04

    (449 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeSite Hemodialysis Access System provides fully implantable blood access for chronic (long term) hemodialysis. It is intended for use in patients who would otherwise be treated with standard cuffed hemodialysis catheters. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the access site (buttonhole), valve pocket and LifeSite valve.
    Device Description
    The LifeSite Hemodialysis Access System is a dialysis access device comprised of two separate valves and cannulas. One valve/cannula is used as the draw and the other valveleannula is the return. The cannulas are placed in cither the internal or external jugular or subclavian veins. They are manufactured from radiopaque silicone. The cannula ends connect to the valves, which are placed in a subcutancous pocket. The values are manufactured from titanium and stainless steel. When accessed with a 14 gauge, fistula needle the valves internal pinch clamp opens allowing access to the vein via the cannula.
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    K Number
    K001633
    Device Name
    LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000
    Manufacturer
    VASCA, INC.
    Date Cleared
    2000-08-24

    (90 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeSite® Hemodialysis Access System provides fully-implantable blood access for patients who require hemodialysis while waiting for creation and/or maturation of permanent access. A 70% isopropyl alcohol solution is used in conjunction with the LifeSite System for the localized cleansing of the injection site, valve pocket, and LifeSite valve.
    Device Description
    The LifeSite Hemodialysis Access System consists of two primary components: (1) the LifeSite Hemodialysis Access Cannula, and (2) the LifeSite Hemodialysis Access Valve. The valve is surgically placed in a subcutaneous pocket. The cannula, placed into an internal jugular or subclavian vein, is connected to the valve by means of the barbed connector on the valve stem. Vascular access can be achieved by accessing the valve with a needle. Accessories to the LifeSite Hemodialysis Access System, including a tunneler, introducer and Medisystems needle, will be packaged with the system and sold as a unit. Another accessory, the LifeSite Hemodialysis Cannula Exchange Kit will be sold separately.
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