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

    MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES

    K Number: K882383 · Decision Nov 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    22
    Applicant Total
    29
    Review Days
    172

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    Basic Information

    Device Name
    MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
    K Number
    K882383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4075
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    CIVCO Medical Instruments Co., Inc.
    Date Received
    June 9, 1988
    Decision Date
    November 28, 1988
    Product Code
    DWZ
    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
    DWZ Device, Biopsy, Endomyocardial

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