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510(k) Data Aggregation

    K Number
    K161659
    Device Name
    FlexSeal Introducer Sheath with Hydrophilic Coating
    Manufacturer
    Date Cleared
    2016-07-15

    (29 days)

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

    LIBRA MEDICAL 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 Sheath with Hydrophilic Coating contains the following disposable components: - o One sterile introducer sheath with an active spring loaded hemostatic valve - o One sterile radiopaque dilator The FlexSeal™ Introducer Sheath with Hydrophilic Coating consists of an introducer sheath with hydrophilic coating and a dilator. The devices sizes are 14F, 16F and 18F. Three different lengths (20 cm, 28 cm and 35 cm) are available for each FlexSeal introducer size. An active hemostatic valve is integrated into the sheath.
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