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510(k) Data Aggregation

    K Number
    K122856
    Device Name
    CHARTER GUIDEWIRE
    Manufacturer
    BRIVANT, LTD.
    Date Cleared
    2012-10-17

    (29 days)

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

    BRIVANT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Charter™ Guidewires are intended for use in the coronary and peripheral vasculature.
    Device Description
    The Charter™ Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm 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 can be varied to produce various levels of support. The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel
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    K Number
    K120137
    Device Name
    VICTORY GUIDEWIRE (32 MODELS)
    Manufacturer
    BRIVANT, LTD.
    Date Cleared
    2012-02-14

    (28 days)

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

    BRIVANT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.
    Device Description
    The Victory Guidewire range are a disposable medical device designed for single use only. The device is intended to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The family consists of a PTFE coated 195cm or 300cm, 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce 6 various levels of support.
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    K Number
    K103377
    Device Name
    CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
    Manufacturer
    BRIVANT, LTD.
    Date Cleared
    2011-05-18

    (182 days)

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

    BRIVANT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Charter™ Guidewires are intended for use in the coronary and peripheral vasculature.
    Device Description
    The Navilyst Medical Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm or 180cm, 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm 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 can be varied to produce various levels of support. The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel
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    K Number
    K102211
    Device Name
    CRUISER 18 GUIDEWIRE
    Manufacturer
    BRIVANT, LTD.
    Date Cleared
    2010-09-03

    (29 days)

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

    BRIVANT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cruiser-18 Guidewires are intended for use in the peripheral vasculature.
    Device Description
    The guide wire is a disposable medical device designed for single use only. It consists of a 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 13cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. This reduced section is covered with a spring coil of equivalent diameter to the main core body. The coiled segment consists of a stainless steel coil placed over a radiopaque coil made of a platinum tungsten alloy. This coil provides greater visibility on x-ray equipment. The profile of the reduced section is varied to provide a range of products with mixed stiffness.
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    K Number
    K093515
    Device Name
    3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON
    Manufacturer
    BRIVANT, LTD.
    Date Cleared
    2010-02-16

    (95 days)

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

    BRIVANT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.
    Device Description
    The Parodi Guidewire Assembly is a disposable medical device designed for single use only. It is a multi-component system which can be manipulated to vary the stiffness characteristics as required during a procedure. The device is available in 2 main configurations: 2-piece system: Comprising a 0.014" guidewire and Outer 0.035" member. 3-piece system: Comprising a 0.014" guidewire, Outer 0.035" member and an Intermediate stiffener. A 3-piece system is depicted in figure 1 below. The Intermediate Stiffener is not present in a 2-piece system. A hydrophilic coating is applied to the distal portion of the wire of the 0.014" guidewire and the 0.035" outer assembly. PTFE coating is applied to the proximal portions of these devices. The wire is packaged in a polyethylene hoop contained within a sealed pouch. A torque device is included within the pouch to assist with torquing the device if required.
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    K Number
    K083094
    Device Name
    STREAMER POLYMER GUIDEWIRE
    Manufacturer
    BRIVANT, LTD.
    Date Cleared
    2009-07-07

    (263 days)

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

    BRIVANT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Streamer Polymer guide wires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional catheters with compatible guidewire lumen and Biotronik coronary venous leads.
    Device Description
    The Biotronik Streamer polymer guide wire is a disposable medical device designed for single use only. It consists of a PTFE coated 195cm 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 38cm 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, standard support, extra support (ES) and extra distal support (XT). There are a total of 8 versions of the guidewire, 2 standard support versions (straight & J), 4 extra support versions (straight and ), Bulach and Berlin) and 2 extra distal support versions (straight & J}. The distal part of the reduced section is covered with a platinum tungsten spring coil of equivalent diameter to the main core body. This provides greater visibility on x-ray equipment. A 30cm length of blue heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD. The polymer jacket over distal coils provides for smoother lead-guidewire interaction.
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    K Number
    K073082
    Device Name
    CPS COURIER GUIDEWIRE
    Manufacturer
    BRIVANT, LTD.
    Date Cleared
    2008-01-09

    (69 days)

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

    BRIVANT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CPS Courier Guidewires are intended for use in the coronary and peripheral vasculature.
    Device Description
    The Courier Guide wire is a disposable medical device designed for single use only. It consists of a 0.014" diameter stainless steel core wire, the distal end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. The quide wire comes in 5 unique base models distinguished by their distal flexibility portions, the profile varied to provide a range of products of mixed stiffness. This reduced section is covered with a polymer coating of equivalent diameter to the main core body. Underneath the polymer at the distal tip there is a 0.010" platinum/tungsten alloy platinum coil attached to the distal tip of the core by means of solder joints. This provides greater visibility on x-ray equipment.
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