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

    BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

    K Number: K925369 · Decision Mar 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    20
    Review Days
    154

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    Basic Information

    Device Name
    BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
    K Number
    K925369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    October 23, 1992
    Decision Date
    March 26, 1993
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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    Other Clearances by Sorin Biomedica, Fiat, USA, Inc.

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