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

    APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    K Number: K020997 · Decision Apr 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    249
    Applicant Total
    22
    Review Days
    7

    Basic Information

    Device Name
    APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
    K Number
    K020997
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DIDECO S.P.A.
    Date Received
    March 28, 2002
    Decision Date
    April 4, 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 DIDECO S.P.A.

    K Number Device Name
    K041061 D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
    K033323 D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
    K033987 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
    K033714 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
    K032040 IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
    K031223 SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
    K030154 IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
    K021732 DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
    K022450 INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
    K020647 DIDECO ELECTA
    Search all 22 clearances from DIDECO S.P.A. →