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

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    K Number: K953835 · Decision Mar 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    6
    Review Days
    212

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    Basic Information

    Device Name
    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
    K Number
    K953835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dideco S.R.L.
    Date Received
    August 16, 1995
    Decision Date
    March 15, 1996
    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.R.L.

    K Number Device Name
    K052717 D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
    K051232 D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER
    K050890 ECC.O SYSTEM
    K050447 PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
    K043323 D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR