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510(k) Data Aggregation

    K Number
    K073260
    Device Name
    LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
    Manufacturer
    DEVICE PARTNERS INTERNATIONAL
    Date Cleared
    2008-03-13

    (114 days)

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

    DEVICE PARTNERS INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LiiSA Lever Integrated Interventional System Adaptor™ is a Y-Connector and hemostasis valve which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic or interventional devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.
    Device Description
    The LiiSA Lever Integrated Interventional System AdaptorTM is an Adaptor designed for use in all interventional applications where a hemostasis valve is required and has an inner diameter of up to 9 F ( 3.0 mm / 0.118"). It has a seal which can be opened and closed by control of a lever. Pushing the lever will open the seal; releasing the lever will close the seal. The lever can be rested in a partially open position or a fully open position. These positions can easily be identified by the position of the lever and by an audible "click". The lever can be further controlled with great sensitivity to have the optimal seal around the interventional device (i.e., guide wire, balloon catheter, stent). This enables the user to experience a minimum of back bleeding with maximum security for his introduced device. The LiiSA Lever Integrated Interventional System AdaptorTM offers two external arms for the purpose of locking introduced devices (i.e., guide wire) to enable users to introduce additional devices without the need to manually hold and secure the devices already introduced and secured. The LiiSA Lever Integrated Interventional System AdaptorTM has a "Y" side arm to facilitate contrast media injection, saline flush and blood pressure monitoring.
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