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

    ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD

    K Number: K924388 · Decision Oct 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    2
    Review Days
    416

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    Basic Information

    Device Name
    ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD
    K Number
    K924388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Angemed, Inc.
    Date Received
    August 31, 1992
    Decision Date
    October 21, 1993
    Product Code
    LDF
    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
    LDF Electrode, Pacemaker, Temporary

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    Other Clearances by Angemed, Inc.

    K Number Device Name
    K924390 ANGEMED 5000 LEAD ADAPTER