BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    PMA: P240004 · Supplement: S002 · Decision Jul 10, 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
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    SEQ
    Generic Name
    Covered stent vascular connector, hemodialysis access circuit
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 10, 2025
    Date Received
    June 12, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of changes to the Austenite finish (Af) temperature specification for the Nitinol Connector Frame of the EndoForce Connector for Endovascular Venous Anastomosis

    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