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

    NAMIC ONE PART INTRODUCER NEEDLE

    K Number: K871382 · Decision May 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    28
    Review Days
    29

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    Basic Information

    Device Name
    NAMIC ONE PART INTRODUCER NEEDLE
    K Number
    K871382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    North American Instrument Corp.
    Date Received
    April 7, 1987
    Decision Date
    May 6, 1987
    Product Code
    DRC
    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
    DRC Trocar

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