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

    MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150

    K Number: K926357 · Decision Jun 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    36
    Applicant Total
    13
    Review Days
    163

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    Basic Information

    Device Name
    MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150
    K Number
    K926357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Bio-Medicus, Inc.
    Date Received
    December 21, 1992
    Decision Date
    June 2, 1993
    Product Code
    DWA
    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
    DWA Control, Pump Speed, Cardiopulmonary Bypass

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    K924206 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
    K924205 MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
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