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510(k) Data Aggregation

    K Number
    K060927
    Device Name
    CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
    Date Cleared
    2006-10-06

    (185 days)

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

    CERES MEDICAL SYSTEMS, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ceres PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
    Device Description
    The Ceres PTA catheter is a single-use, sterile balloon dilation catheter for angioplasty. A double lumen coaxial shaft features an inflatable balloon at its distal end. The proximal end provides a double hub connector, whose first port allows the attachment of an inflatable device which is used to inflate and deflate the balloon through the outer lumen. A second hub port allows the advance of a guidewire throughout the entire length of the catheter using the distally open inner lumen. Platinum radiopaque bands are used to locate the balloon under fluoroscopy.
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