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510(k) Data Aggregation

    K Number
    K222185
    Device Name
    Stratus Infusion Catheter
    Manufacturer
    InterVene, Inc.
    Date Cleared
    2023-04-13

    (265 days)

    Product Code
    NPG
    Regulation Number
    870.1210
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    Product Code :

    NPG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.
    Device Description
    The Stratus™ Infusion Catheter is a peripheral infusion catheter designed to access an intraluminal, intramural, or perivascular vein wall layer and infuse fluid diagnostic and/or therapeutic agents. The Stratus Infusion Catheter is a non-implantable device that is provided sterile and is intended for single patient use. The Stratus Infusion Catheter is designed to accommodate individual vein anatomies or disease progression (e.g., thrombosis), by the catheter platform allowing multiple infusions and infusion locations per device.
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