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

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    K Number: K112771 · Decision Oct 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    167
    Applicant Total
    29
    Review Days
    21

    Basic Information

    Device Name
    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
    K Number
    K112771
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SORIN GROUP ITALIA S.R.L.
    Date Received
    September 23, 2011
    Decision Date
    October 14, 2011
    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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