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510(k) Data Aggregation

    K Number
    K102147
    Device Name
    CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
    Manufacturer
    CARDIOQUIP LLP
    Date Cleared
    2010-11-19

    (112 days)

    Product Code
    DWC
    Regulation Number
    870.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOQUIP LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
    Device Description
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