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

    SARNS MEMBRANE OXGENATOR PART NUMBER 9443

    K Number: K903436 · Decision Oct 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    76
    Review Days
    80

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    Basic Information

    Device Name
    SARNS MEMBRANE OXGENATOR PART NUMBER 9443
    K Number
    K903436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    July 31, 1990
    Decision Date
    October 19, 1990
    Product Code
    DTZ
    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
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by 3M Health Care, Sarns

    K Number Device Name
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    K935977 SARNS AIR DETECTION SYSTEM
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