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

    CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200

    K Number: K032068 · Decision Aug 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    4
    Review Days
    50

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    Basic Information

    Device Name
    CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
    K Number
    K032068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovention, Inc.
    Date Received
    July 3, 2003
    Decision Date
    August 22, 2003
    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 Cardiovention, Inc.

    K Number Device Name
    K030141 MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
    K021694 CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
    K012325 CARDIOVENTION CORX SYSTEM, MODEL FG 0001