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510(k) Data Aggregation

    K Number
    K140796
    Device Name
    MEDUSA VASCULAR PLUG,
    Manufacturer
    Date Cleared
    2014-12-02

    (246 days)

    Product Code
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOSHAPE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.
    Device Description
    The Medusa™ Vascular Plug is a coil-based occlusion device intended for embolization procedures in the peripheral vasculature. The Medusa™ Vascular Plug consists of an implant and a delivery system. The implant is constructed of multiple polymer coils that are pre-loaded on to the delivery system. The Medusa™ Vascular Plug coils are delivered concurrently for vascular occlusion in a single application. Like predicate embolic coils, vascular occlusion with the Medusa™ Vascular Plug is achieved by mechanical flow restriction resulting from coil pack delivery that leads to thrombus formation and rapid cessation of blood flow.
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    K Number
    K123696
    Device Name
    MEDUSA VASCULAR PLUG
    Manufacturer
    Date Cleared
    2013-10-25

    (326 days)

    Product Code
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOSHAPE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained and experienced in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.
    Device Description
    The Medusa™ Vascular Plug is a coil-based occlusion device intended for embolization procedures in the peripheral vasculature. The Medusa™ Vascular Plug consists of an implant and a delivery system. The implant is constructed of multiple polymer coils that are pre-loaded on to the delivery system. The Medusa™ Vascular Plug coils are delivered concurrently for vascular occlusion in a single application. Like predicate embolic coils, vascular occlusion with the Medusa™ Vascular Plug is achieved by mechanical flow restriction resulting from coil pack delivery that leads to thrombus formation and rapid cessation of blood flow.
    Ask a Question

    Ask a specific question about this device

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