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510(k) Data Aggregation

    K Number
    K200083
    Device Name
    EMBA Hourglass Peripheral Embolization Device (PED)
    Manufacturer
    Embolic Acceleration, LLC
    Date Cleared
    2020-02-14

    (30 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Embolic Acceleration, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EMBA Hourglass® Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
    Device Description
    The Hourglass® Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding hourglass-shaped structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.
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