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510(k) Data Aggregation

    K Number
    K143652
    Device Name
    Vector PTA Balloon Dilatation Catheter
    Date Cleared
    2015-02-26

    (65 days)

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

    Vector Corporation LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vector™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae. The Vector" Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.
    Device Description
    The Vector™ PTA Balloon Dilatation Catheter is a high pressure, non-compliant balloon catheter. It is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to the 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The balloon is a high pressure composite balloon with radio-opaque marker bands to help visualize the balloon placement within the vasculature during both placement and inflation. The balloon's rated burst pressure is 30 atm.
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