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

    A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000

    K Number: K992592 · Decision May 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    4
    Review Days
    276

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    Basic Information

    Device Name
    A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
    K Number
    K992592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A-Med Systems, Inc.
    Date Received
    August 2, 1999
    Decision Date
    May 4, 2000
    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 A-Med Systems, Inc.

    K Number Device Name
    K020529 LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
    K013393 HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
    K991541 A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44