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510(k) Data Aggregation

    K Number
    K182457
    Device Name
    Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
    Manufacturer
    Brivant Limited (Lake Region Medical)
    Date Cleared
    2019-04-18

    (223 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Brivant Limited (Lake Region Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
    Device Description
    The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity). The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity. Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long. When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA). Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.
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    K Number
    K141831
    Device Name
    HYDRAVIEW GUIDEWIRE
    Manufacturer
    BRIVANT LIMITED
    Date Cleared
    2014-09-04

    (59 days)

    Product Code
    DQX, DOX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRIVANT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydraView Polymer Guidewires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional devices with compatible guidewire lumen and compatible coronary venous leads.
    Device Description
    The HydraView Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 190cm, 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 30cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support; ES, DS and EDS.
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    K Number
    K060551
    Device Name
    BRIVANT GUIDEWIRE
    Manufacturer
    BRIVANT LIMITED
    Date Cleared
    2006-06-07

    (97 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRIVANT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Brivant guidewires are intended for use in the coronary and peripheral vasculature.
    Device Description
    The Brivant Guidewire is a disposable medical device designed for single use only. It consists of a 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over the distal coil segment in a progressive fashion. The Brivant Guidewire is produced in lengths of 175, 195 and 300cm and is available in either silicone or hydrophilic coatings. The profile of the reduced section is varied to provide a range of products of mixed stiffness.
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