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

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    K Number: K991864 · Decision Aug 31, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    2
    Review Days
    457

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    Basic Information

    Device Name
    ROTAFLOW CENTRIFUGAL PUMP SYSTEM
    K Number
    K991864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jostra Medizintechnik AG
    Date Received
    June 1, 1999
    Decision Date
    August 31, 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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