BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR

    K Number: K770681 · Decision Apr 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    41
    Applicant Total
    109
    Review Days
    15

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    Basic Information

    Device Name
    VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
    K Number
    K770681
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Scimed Life Systems, Inc.
    Date Received
    April 11, 1977
    Decision Date
    April 26, 1977
    Product Code
    KRI
    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
    KRI Accessory Equipment, Cardiopulmonary Bypass

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