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510(k) Data Aggregation

    K Number
    K210681
    Device Name
    SiteSeal SV
    Manufacturer
    Ensite Vascular
    Date Cleared
    2021-04-06

    (29 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ensite Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure or the brachial artery after a transbrachial procedure.
    Device Description
    Not Found
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    K Number
    K190351
    Device Name
    Site Seal SV
    Manufacturer
    Ensite Vascular
    Date Cleared
    2019-07-02

    (138 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ensite Vascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.
    Device Description
    The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.
    Ask a Question

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