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

    COBE CENTURY PERFUSION PUMP

    K Number: K960974 · Decision Jul 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    20
    Applicant Total
    43
    Review Days
    490

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    Basic Information

    Device Name
    COBE CENTURY PERFUSION PUMP
    K Number
    K960974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cobe Cardiovascular, Inc.
    Date Received
    March 11, 1996
    Decision Date
    July 14, 1997
    Product Code
    DWB
    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
    DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

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    K030462 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
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    K013480 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
    K012763 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
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