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

    SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045

    K Number: K022281 · Decision Aug 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    6
    Review Days
    22

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    Basic Information

    Device Name
    SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
    K Number
    K022281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polystan A/S
    Date Received
    July 15, 2002
    Decision Date
    August 6, 2002
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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    Other Clearances by Polystan A/S

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    K953976 SAFE MICRO
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