BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    PMA: P240004 · Decision May 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Covered Stent Vascular Connector, Hemodialysis Access Circuit
    Trade Name
    EndoForce Connector for Endovascular Venous Anastomosis
    PMA Number
    P240004
    Device Class
    FDA Class 3
    Product Code
    SEQ
    Generic Name
    Covered stent vascular connector, hemodialysis access circuit
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 15, 2025
    Date Received
    March 8, 2024
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Phraxis, Inc. EndoForce Connector for Endovascular Venous Anastomosis. This device is indicated to provide an endovascular method for attachment of an arteriovenous graft to a vein in the upper arm in patients with end stage renal disease requiring hemodialysis. The EndoForce Connector is used together with conventional suturing of the graft to the artery during the implantation procedure. The graft is then used for vascular access during hemodialysis.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SEQ Covered Stent Vascular Connector, Hemodialysis Access Circuit