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510(k) Data Aggregation

    K Number
    K233357
    Device Name
    EsoCool Thermal Regulation Catheter
    Manufacturer
    Nuvaira, Inc.
    Date Cleared
    2024-06-27

    (272 days)

    Product Code
    PLA
    Regulation Number
    870.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nuvaira, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EsoCool catheter is a thermal regulating device intended to connect to a Gentherm Blanketrol III Hyper-Hypothermia System to control the patient temperature.
    Device Description
    The EsoCool Thermal Regulation Catheter is a dual lumen tube that is placed in the esophagus. The two lumens are connected to an external heater cooler to allow for circulation of cold or warm fluid in a closed loop system. Heater cooler control is used to modulate the fluid temperature and control of patient's temperature. The EsoCool catheter is made of polyurethane with barium sulfate for radiopacity. The EsoCool catheter is a single-use, disposable, non-implantable device with an intended duration of use of 24 hours or less.
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