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510(k) Data Aggregation

    K Number
    K171845
    Device Name
    EMBA Hourglass Peripheral Embolization Device
    Manufacturer
    EMBA Medical Limited
    Date Cleared
    2017-08-18

    (59 days)

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

    EMBA Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EMBA 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 EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding 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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