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

    CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100

    K Number: K021694 · Decision Jan 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    51
    Applicant Total
    4
    Review Days
    231

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    Basic Information

    Device Name
    CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
    K Number
    K021694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovention, Inc.
    Date Received
    May 22, 2002
    Decision Date
    January 8, 2003
    Product Code
    DTQ
    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
    DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

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    Other Clearances by Cardiovention, Inc.

    K Number Device Name
    K032068 CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
    K030141 MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
    K012325 CARDIOVENTION CORX SYSTEM, MODEL FG 0001