Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K152665
    Device Name
    PolarCath Peripheral Dilatation System
    Date Cleared
    2015-10-26

    (39 days)

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

    NUCYRO VASCULAR, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
    Device Description
    The PolarCath™ Peripheral Dilatation System (PolarCath System) consists of a disposable catheter, a reusable Cryoplasty inflation unit, a disposable nitrous oxide cartridge, and a disposable catheter extension. The PolarCath System is designed for dilatation of stenotic lesions in peripheral arteries. The procedure consists of inserting a catheter over a quidewire to the target lesion, attaching the catheter to the catheter extension, attaching the catheter extension to the Inflation Unit, inserting a nitrous oxide cartridge into the Inflation Unit, and inflating the balloon catheter for a set time at a set pressure, using the controls on the Inflation Unit. The Cryoplasty inflation unit functions to: a) deliver the inflation media (liquid nitrous oxide) to the balloon; b) control the pressure inside the inner balloon; c) provide a vacuum between the inner and outer balloons; and d) control the length of time for delivery of the inflation media which is manually extracted at the end of the inflation time. The inflation unit monitors the temperature inside the balloon. Excess pressure is prevented by the presence of a relief valve in the inflation unit.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1