BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Neurovascular Liquid Embolic Agent

    PMA: P250009 · Decision Jan 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Neurovascular Liquid Embolic Agent
    Trade Name
    SQUID Liquid Embolic Agent (LEA)
    PMA Number
    P250009
    Device Class
    FDA Class 3
    Product Code
    SGU
    Generic Name
    Neurovascular Liquid Embolic Agent
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 30, 2026
    Date Received
    March 21, 2025
    Expedited Review
    N
    Docket Number
    FDA-1387

    Advisory Committee Statement

    The SQUID Liquid Embolic Agent is indicated for the embolization of the middle meningeal artery (MMA) as an adjunct to usual care treatment in patients with symptomatic chronic subdural hematoma(s) (SDH) measuring 10 mm or greater in thickness in whom an intervention is deemed necessary as determined by a neurosurgeon.

    Classifications

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

    Product Code Device Name
    SGU Neurovascular Liquid Embolic Agent