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

    Arctx Cool Catheter Set

    K Number: K250632 · Decision Oct 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    241

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    Basic Information

    Device Name
    Arctx Cool Catheter Set
    K Number
    K250632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arctx Medical
    Date Received
    March 3, 2025
    Decision Date
    October 30, 2025
    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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