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

    ARTAIRA Arterial Compression Device (AACD01)

    K Number: K240499 · Decision Oct 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    7
    Review Days
    234

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    Basic Information

    Device Name
    ARTAIRA Arterial Compression Device (AACD01)
    K Number
    K240499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Airos Medical, Inc.
    Date Received
    February 20, 2024
    Decision Date
    October 11, 2024
    Product Code
    JOW
    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
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Airos Medical, Inc.

    K Number Device Name
    K223193 AIROS 8P Sequential Compression Device
    K223195 AIROS 6P Sequential Compression Device
    K193068 AIROS 8 Sequential Compression Device
    K193069 AIROS 6 Sequential Compression Device
    K172770 AIROS 6 Sequential Compression Device
    K172779 AIROS 8 Sequential Compression Device