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

    VASCUTRAK PTA DILATION CATHETER

    K Number: K063657 · Decision Dec 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    4

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    Basic Information

    Device Name
    VASCUTRAK PTA DILATION CATHETER
    K Number
    K063657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ymed, Inc.
    Date Received
    December 8, 2006
    Decision Date
    December 12, 2006
    Product Code
    PNO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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 Ymed, Inc.

    K Number Device Name
    K082343 VASCUTRAK 2, MODELS: V14 AND V18