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510(k) Data Aggregation

    K Number
    K243436
    Device Name
    Seclusion Catheter
    Manufacturer
    Basis Medical
    Date Cleared
    2025-02-28

    (115 days)

    Product Code
    DQYDOY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Basis Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Secusion Catheter is indicated for localized infusion and aspiration of various therapeutic agents in isolated segments of the peripheral venous vasculature. The Seclusion Catheter may be repositioned for multiple treatments with the same patient. The Seclusion Catheter is not indicated for use in the neurovasculature.
    Device Description
    The Seclusion Catheter is indicated for localized infusion and aspiration of various therapeutic and diagnostic agents in isolated segments of the peripheral venous vasculature. The Seclusion Catheter may be repositioned for multiple treatments with the same patient. A photograph of the Seclusion Catheter is shown in the figures below. The device is EtO sterilized and is a single-use device.
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