BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30

    K Number: K090555 · Decision Dec 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    44
    Review Days
    296

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    Basic Information

    Device Name
    PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
    K Number
    K090555
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maquet Cardiopulmonary, AG
    Date Received
    March 2, 2009
    Decision Date
    December 23, 2009
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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    Other Clearances by Maquet Cardiopulmonary, AG

    K Number Device Name
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    K141432 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
    K133598 CARDIOHELP SYSTEM
    K133265 QUADROX-IR ADULT AND SMALL ADULT
    K132166 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
    K132829 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
    K131666 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
    K130300 HEATER-COOLER UNIT HCU 40
    K123288 HEMOCONCENTRATOR
    Search all 44 clearances from Maquet Cardiopulmonary, AG →