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

    BIPOLAR ENDOCARDIAL LEAD 406L

    K Number: K841227 · Decision Nov 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    63
    Review Days
    250

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    Basic Information

    Device Name
    BIPOLAR ENDOCARDIAL LEAD 406L
    K Number
    K841227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Siemens Elema AB
    Date Received
    March 22, 1984
    Decision Date
    November 27, 1984
    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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