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

    CARDIOVENTION CORX SYSTEM, MODEL FG 0001

    K Number: K012325 · Decision Apr 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    4
    Review Days
    260

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    Basic Information

    Device Name
    CARDIOVENTION CORX SYSTEM, MODEL FG 0001
    K Number
    K012325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovention, Inc.
    Date Received
    July 23, 2001
    Decision Date
    April 9, 2002
    Product Code
    KFM
    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
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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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
    K021694 CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100