BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    PMA: P240004 · Supplement: S001 · Decision Jul 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Covered Stent Vascular Connector, Hemodialysis Access Circuit
    Trade Name
    EndoForce™ Connector for Endovascular Venous Anastomosis
    PMA Number
    P240004
    Supplement Number
    S001
    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
    July 18, 2025
    Date Received
    June 6, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the EndoForce Post-Approval Study submitted to comply with the conditions of approval outlined in the approval order for P240004.

    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