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

    CSS-CARDIOPLEGIA SAFETY SYSTEM

    K Number: K973237 · Decision Apr 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    20
    Applicant Total
    13
    Review Days
    242

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    Basic Information

    Device Name
    CSS-CARDIOPLEGIA SAFETY SYSTEM
    K Number
    K973237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Bio-Medicus, Inc.
    Date Received
    August 28, 1997
    Decision Date
    April 27, 1998
    Product Code
    DWB
    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
    DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

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