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510(k) Data Aggregation

    K Number
    K031323
    Device Name
    DBT, DYNAMIC BUBBLE TRAP
    Manufacturer
    Date Cleared
    2003-08-01

    (98 days)

    Product Code
    Regulation Number
    870.4260
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONVERGENZA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DBT™ is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.
    Device Description
    The DBT™, Dynamic Bubble Trap is a sterile device with a non-pyrogenic fluid pathway. It is intended for single use only, in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures. It is designed to remove gaseous microemboli from the arterial line of a cardiopulmonary bypass circuit.
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