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

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR

    K Number: K010478 · Decision Sep 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    5
    Review Days
    219

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    Basic Information

    Device Name
    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR
    K Number
    K010478
    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
    February 20, 2001
    Decision Date
    September 27, 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
    K004001 MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
    K001388 DATA MASTER PERFUSION MONITORING SYSTEM
    K936220 DIDECO VACUUM PUMP
    K940519 DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM