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510(k) Data Aggregation

    K Number
    K082412
    Device Name
    VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
    Manufacturer
    MAPQUET CARDIOPULMONARY AG
    Date Cleared
    2008-11-10

    (81 days)

    Product Code
    DTP
    Regulation Number
    870.4230
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAPQUET CARDIOPULMONARY AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.
    Device Description
    The Venous Bubble Trap is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The device is sterilized with Ethylene Oxide. The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation. The device is to be used for up to 6 hours.
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