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    K Number
    K011646
    Device Name
    NEUROEDGE INFUSION CATHETER
    Manufacturer
    NEURO VASX, INC.
    Date Cleared
    2001-08-27

    (90 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO VASX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.
    Device Description
    The NeuroEdge™ Infusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroEdge™ Infusion Catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid agents (such as contrast media and liquid embolic glues) through the end hole at select sites in the neurovasculature for the diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms. The catheter is also designed to penetrate an embolism if it is determined to be a soft thrombus and navigate through the thrombus to assess the circulation distal to the thrombus. The NeuroEdge™ Infusion Catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized via gamma radiation sterilization process.
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    K Number
    K984258
    Device Name
    NEUROVASX SUB-MICROINFUSION CATHETER
    Manufacturer
    NEURO VASX, INC.
    Date Cleared
    1999-02-11

    (73 days)

    Product Code
    DQOJCY
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO VASX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeuroVasx Sub-Microinfusion Catheter is intended for the delivery of diagnostic agents into the neurovasculature.
    Device Description
    The NeuroVasx Sub-Microinfusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroVasx catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid diagnostic agents radially through side holes in the wall of the catheter to improve the diffusion and mixing of the infused agent with the blood flow. The NeuroVasx catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized in a gamma radiation sterilization process.
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