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    K Number
    K030742
    Device Name
    POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
    Manufacturer
    CRYO VASCULAR SYSTEMS INC.
    Date Cleared
    2003-08-29

    (172 days)

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

    CRYO VASCULAR SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolarCath Peripheral Balloon Catheter System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal. infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or native arteriovenous dialysis fistulae.
    Device Description
    The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.
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    K Number
    K022061
    Device Name
    CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER
    Manufacturer
    CRYO VASCULAR SYSTEMS INC.
    Date Cleared
    2002-09-20

    (87 days)

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

    CRYO VASCULAR SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CVSi™ Peripheral Balloon Catheter and the CVSi™ Inflator are indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.
    Device Description
    The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSi™ Inflator, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 12 gr cylinder.
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