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

    LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP

    K Number: K921550 · Decision May 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    23
    Review Days
    58

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    Basic Information

    Device Name
    LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
    K Number
    K921550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    St. Jude Medical, Inc.
    Date Received
    March 24, 1992
    Decision Date
    May 21, 1992
    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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