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

    FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH

    K Number: K032884 · Decision Aug 6, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    325

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    Basic Information

    Device Name
    FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
    K Number
    K032884
    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 Epi
    Date Received
    September 16, 2003
    Decision Date
    August 6, 2004
    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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    Other Clearances by Boston Scientific Epi

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