BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    ESOPHAGEAL COOLING DEVICE

    K Number: DEN140018 · Decision Jun 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    410

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    Basic Information

    Device Name
    ESOPHAGEAL COOLING DEVICE
    K Number
    DEN140018
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.5910
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Advanced Cooling Therapy, LLC
    Date Received
    May 9, 2014
    Decision Date
    June 23, 2015
    Product Code
    PLA
    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
    PLA Esophageal Thermal Regulation And Gastric Suctioning Device

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    Other Clearances by Advanced Cooling Therapy, LLC

    K Number Device Name
    K170009 Esophageal Cooling Device
    K152450 Esophageal Cooling Device