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510(k) Data Aggregation

    K Number
    K042060
    Device Name
    EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
    Manufacturer
    MILLIMED A/S
    Date Cleared
    2004-10-06

    (68 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLIMED A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller. The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter. The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.
    Device Description
    The EasyPass™ US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a sidearm and a hemostasis valve. To open the hemostasis valve, a valve opener cap with a center passage tube is pushed distally. The hemostasis valve is closed by pulling the valve opener cap proximally. The passage tube on the valve opener provides a completely opened and smooth lumen for the insertion of interventional devices.
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