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

    CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700

    K Number: K884640 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    41
    Applicant Total
    20
    Review Days
    78

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    Basic Information

    Device Name
    CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
    K Number
    K884640
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Omni Medical, Inc.
    Date Received
    November 7, 1988
    Decision Date
    January 24, 1989
    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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    K873802 PRESSURE BARRIER KIT CAT. NO. PBK-3
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