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

    MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR

    K Number: K004001 · Decision Oct 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    249
    Applicant Total
    5
    Review Days
    282

    Basic Information

    Device Name
    MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
    K Number
    K004001
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DIDECO
    Date Received
    December 26, 2000
    Decision Date
    October 4, 2001
    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 DIDECO

    K Number Device Name
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    K001388 DATA MASTER PERFUSION MONITORING SYSTEM
    K936220 DIDECO VACUUM PUMP
    K940519 DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM