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

    MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG

    K Number: K911790 · Decision Aug 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    475
    Review Days
    112

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    Basic Information

    Device Name
    MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
    K Number
    K911790
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtronic Vascular
    Date Received
    April 22, 1991
    Decision Date
    August 12, 1991
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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