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510(k) Data Aggregation

    K Number
    K143093
    Device Name
    0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
    Manufacturer
    HOTSPUR TECHNOLOGIES, INC.,
    Date Cleared
    2015-06-24

    (239 days)

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

    HOTSPUR TECHNOLOGIES, INC.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 0.018" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
    Device Description
    The .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is an 0.018" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows iniection of fluids through the inflation lumen without removal of the quidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers identify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a quidewire female luer lock hub in the proximal end of the handle. Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.
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    K Number
    K142300
    Device Name
    Arrow GPSCath Balloon Dialation Catheter (150 cm)
    Manufacturer
    HOTSPUR TECHNOLOGIES, INC.,
    Date Cleared
    2014-09-17

    (30 days)

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

    HOTSPUR TECHNOLOGIES, INC.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow GPSCath Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
    Device Description
    The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle. Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.
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