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510(k) Data Aggregation

    K Number
    K190628
    Device Name
    FlexSeal Introducer Sheath with Hydrophilic Coating
    Date Cleared
    2019-05-30

    (79 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Freudenberg Medical MIS, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FlexSeal® Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices, and to minimize blood loss associated with such insertions.
    Device Description
    The FlexSeal Introducer set contains the following disposable components: One sterile introducer sheath with an active spring loaded hemostatic valve ● One sterile radiopaque dilator The FlexSeal Introducer set consists of an introducer sheath with hydrophilic coating and a dilator. The device size is 21Fr with a 56 cm shaft. An active hemostatic valve is integrated into the sheath. A Ring Lock at the proximal end of the device assists with the control of the hemostatic valve.
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