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510(k) Data Aggregation

    K Number
    K193322
    Device Name
    NovaCross CTO Microcatheter
    Manufacturer
    Date Cleared
    2020-04-02

    (122 days)

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

    Nitiloop Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NovaCross CTO Microcatheter is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond the stenotic lesions, including chronic total occlusions (CTOs), and prior to PTCA or stent intervention. It is also intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
    Device Description
    The NovaCross™ CTO Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention and to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature. The NovaCross™ CTO Microcatheter consists of stainless steel shaft, Over Tube, and a proximal Handle Body that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and collapsible distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site.
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    K Number
    K172297
    Device Name
    NovaCross Microcatheter
    Manufacturer
    Date Cleared
    2017-10-18

    (79 days)

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

    Nitiloop Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
    Device Description
    The NovaCross™ Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange. The NovaCross™ Microcatheter consists of telescopic shaft, over tube, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site.
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    K Number
    K160389
    Device Name
    NovaCross Microcatheter
    Manufacturer
    Date Cleared
    2016-03-11

    (29 days)

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

    Nitiloop Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
    Device Description
    The NovaCross™ Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange. The NovaCross™ Microcatheter consists of telescopic shaft, over tube, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide anchoring to aid the user in establishing greater support near the treatment site.
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    K Number
    K143608
    Device Name
    NovaCross Microcatheter
    Manufacturer
    Date Cleared
    2015-05-04

    (136 days)

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

    Nitiloop Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NovaCross Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
    Device Description
    The NovaCross™ Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange. The NovaCross™ Microcatheter consists of telescopic shaft. Over Tube, and a proximal Handle Body that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide an anchoring to aid the user in establishing greater support near the treatment site. Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The NovaCross™ Microcatheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The NovaCross™ Microcatheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.
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