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

    SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT

    K Number: K915547 · Decision Sep 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    82
    Applicant Total
    76
    Review Days
    638

    Basic Information

    Device Name
    SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
    K Number
    K915547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M HEALTH CARE, SARNS
    Date Received
    December 11, 1991
    Decision Date
    September 9, 1993
    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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