BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010

    K Number: K013038 · Decision Aug 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    6
    Review Days
    338

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    Basic Information

    Device Name
    SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
    K Number
    K013038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polystan A/S
    Date Received
    September 10, 2001
    Decision Date
    August 14, 2002
    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 Polystan A/S

    K Number Device Name
    K023251 PEDIATRIC ARTERIAL CANNULA
    K022281 SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
    K980974 SAFE MINI
    K953976 SAFE MICRO
    K912082 SAFE II