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

    SPIDERFX EMBOLIC PROTECTION DEVICE

    K Number: K063785 · Decision Jan 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    21
    Applicant Total
    35
    Review Days
    29

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    Basic Information

    Device Name
    SPIDERFX EMBOLIC PROTECTION DEVICE
    K Number
    K063785
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ev3, Inc.
    Date Received
    December 21, 2006
    Decision Date
    January 19, 2007
    Product Code
    NFA
    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
    NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

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