BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PERIPHERAL CUTTING BALLOON

    K Number: K051254 · Decision Jun 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    37

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    Basic Information

    Device Name
    PERIPHERAL CUTTING BALLOON
    K Number
    K051254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Ivt
    Date Received
    May 16, 2005
    Decision Date
    June 22, 2005
    Product Code
    PNO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNO Catheter, Percutaneous, Cutting/Scoring

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    Other Clearances by Boston Scientific Ivt

    K Number Device Name
    K041993 2 CM PERIPHERAL CUTTING BALOON