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510(k) Data Aggregation

    K Number
    K043534
    Device Name
    MODIFICATION TO OUTBACK CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2005-01-21

    (30 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Outback® Catheter is intended to facilitate placement and positioning of guide wires / catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved ip is positioned coaxially within the nosecone. In this configuration the catherer may be tracked over a guide wire to the sclected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance. Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.
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    K Number
    K040771
    Device Name
    MODIFICATION TO OUTBACK CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2004-04-23

    (29 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Outback® Catheter is intended to facilitate placement and positioning of guidewires/catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved tip is positioned coaxially within the noscone. In this configuration the catheter may be tracked over a guide wire to the selected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance. Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.
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    K Number
    K033535
    Device Name
    LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2004-01-07

    (58 days)

    Product Code
    PDU, DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LuMend Frontrunner® CTO Catheter and Accessories are intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
    Device Description
    The LuMend Frontrunner® CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator und a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, an optional guide wire lumen and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. Guidance and tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator and/or the use of a guide wire.
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    K Number
    K032298
    Device Name
    MODIFICATION TO OUTBACK CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2003-08-26

    (32 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Outback® Catheter is intended to facilitate placement and positioning of guide wires/ catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The Outback catheter is comprised of four primary elements: 1) guide 2) catheter shaft 3) rotating hemostasis valve (RHV) and 4) deployment handle or control knob. The guide is a single-lumen, steel braided polyimide shaft that can be extended or retracted by the control knob. The tubular catheter shaft houses this guide and is also steel braided polyimide in composition. The rotating hemostasis valve (RHV) has two functions: a one way valve allows for flushing of the catheter while a locking hub at the proximal end of the RHV controls the retracted position of the guide. The fourth component is the deployment handle/control knob that is used to extend or retract the guide. This control knob also functions as a port with a luer fitting for flushing of the guide wire lumen.
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    K Number
    K031005
    Device Name
    LUMEND FRONTRUNNER GW CTO CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2003-06-18

    (79 days)

    Product Code
    PDU, DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LuMend Frontrunner™ GW CTO Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
    Device Description
    The LuMend Frontrunner™ GW CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, an optional guide wire lumen and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. Guidance and tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator and/or the use of a guide wire.
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    K Number
    K023114
    Device Name
    LUMEND FRONTRUNNER CTO CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2003-01-23

    (126 days)

    Product Code
    PDU, DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LuMend Frontrunner™ CTO Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
    Device Description
    The LuMend Frontrunner™ is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. The Frontrunner catheter does not have a guide wire lumen.
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    K Number
    K023223
    Device Name
    MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2002-10-24

    (27 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lessons (including chronic total occlusions) prior to PTCA of stent intervention.
    Device Description
    The LuMend Frontrunner™ CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal braided shaft for push and torque control, a flexible distal shaft which may be manually shaped, and a radiopaque blunt-shaped distal variable-size tip assembly in various shapes and sizes. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. The Frontrunner catheter does not have a guide wire lumen. Guidance and tracking of the catheter through the coronary or peripheral vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator.
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    K Number
    K013284
    Device Name
    LUMEND FRONTRUNNER CTO CORONARY CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2002-02-11

    (132 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LuMend Frontrunner™ CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.
    Device Description
    The LuMend Frontrunner™ is a sterile single-use percutaneous coronary catheter consisting of a handle assembly with an integral rotator and a side port for internal device flushing, a proximal and a radiopaque blunt-shaped distal variable-size tip assembly. A handle lever provides manual adjustment of the size of the tip assembly, and the handle rotator provides rotational control for the shaft and distal tip assembly. The distal assembly consists of a set of bilateral hinged tip pieces. The Frontrunner catheter does not have a guide wire lumen. Guidance and tracking of the catheter through the coronary vasculature is accomplished by selective manual shaping of the flexible distal shaft, and controlled torquing of the handle rotator.
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    K Number
    K011562
    Device Name
    LUMEND PERCUTANEOUS CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2002-01-16

    (240 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable guide wire in order to access discreet regions of the coronary vasculature. It may be used to facilitate placement of guide wires and other interventional devices.
    Device Description
    The LuMend Percutaneous Catheter is a sterile single-use percutaneous coronary catheter consisting of a guide wire lead and handle assembly, proximal and distal shaft and variably curved distal tip. Guidance and tracking of the catheter through the coronary vasculature is accomplished in conjunction with a steerable guide wire.
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    K Number
    K014117
    Device Name
    MODIFICATION TO OUTBACK CATHETER
    Manufacturer
    LUMEND, INC.
    Date Cleared
    2002-01-11

    (28 days)

    Product Code
    DQY, DOY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The Outback catheter features a 6 Fr. steel-braided polyimide and polyurethane shaft through which a single-lumen steel-braided polyimide guide is housed. The guide is extendable and steerable from the tip of the catheter shaft, and features a radiopaque multi-beveled guide tip allowing for visualization under fluoroscopy. A radiopaque index on the catheter shaft is oriented to the steerable guide tip. The proximal end of the Outback Catheter features a rotating hemostasis valve through which the guide is extended and retracted via a rotational handle mechanism.
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