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

    SPIDERX EMBOLIC PROTECTION DEVICE

    K Number: K062201 · Decision Aug 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    21
    Applicant Total
    35
    Review Days
    10

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    Basic Information

    Device Name
    SPIDERX EMBOLIC PROTECTION DEVICE
    K Number
    K062201
    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
    August 1, 2006
    Decision Date
    August 11, 2006
    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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