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510(k) Data Aggregation

    K Number
    K153494
    Device Name
    HQS Introducer (Model 2064-HQS)
    Manufacturer
    Date Cleared
    2016-08-25

    (265 days)

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

    ALSEAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HQS Introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
    Device Description
    Not Found
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    K Number
    K133296
    Device Name
    XCATH
    Manufacturer
    Date Cleared
    2014-02-14

    (112 days)

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

    ALSEAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    XCath (model 2064-XC) is intended to be inserted into the HQS Introducer (model 2064-HQS) to establish multiple and simultaneous conduits through the same vascular access (previously established by the HQS introducer). The whole XCath / HQS allows insertion of several endovascular devices at the same time while minimizing blood loss associated with such insertions.
    Device Description
    The XCath (model 2064-XC) consists of a multiple ways access (2, 3 or 4 ways) adapted to the HQS Introducer (K113849) to optimize the sealing when several vascular tools up to 9,3F need to be introduced through the same vascular access. The device features include (1) a flexible multilumen body, with 2, 3 or 4 channels compatible with the open valve of HQS Introducer; (2) a base with 2, 3 or 4 valves, (3) Extension line for each valve with stopcock and Luer Lock connection. Once the XCath is connected to the HQS Introducer, the device can accommodate vascular tools up to 9,3 French (3,1mm). The XCath (accessory) is fixed in proximal position of the HQS introducer body and allows the simultaneous insertion of several vascular tools.
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    K Number
    K113849
    Device Name
    HQS INTRODUCER
    Manufacturer
    Date Cleared
    2012-07-31

    (215 days)

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

    ALSEAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HQS introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions
    Device Description
    The High Quality Sealing (HQS) Introducer comprises 4 elements, a radio- opaque introducer sheath equipped with a haemostasis valve, a radio- opaque dilator, a centering wire device and an extension line with 3 ways stopcock. The range of HQS introducer (18F, 20F, 22F, 24F, 26F) permits the insertion, preserving sealing, of large caliber tools, from OF, up to the nominal size of-the-introducer-sheath.. The introducer and its adjustable valve are easily handled with one hand. The distal tip is designed to perform an efficient introduction of the HQS introducer with the dilator in the vessel. The centering device permits to introduce a guidewire through the valve and to keep a perfect sealing. The extension line is connected to the lateral port of the introducer for the injection during the procedure.
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