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

    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

    K Number: K041574 · Decision Jul 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    15
    Review Days
    28

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    Basic Information

    Device Name
    CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020
    K Number
    K041574
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guidant Corporation
    Date Received
    June 14, 2004
    Decision Date
    July 12, 2004
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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