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

    Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

    K Number: K243627 · Decision Dec 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    1
    Review Days
    401

    Basic Information

    Device Name
    Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
    K Number
    K243627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arc Trauma, LLC
    Date Received
    November 25, 2024
    Decision Date
    December 31, 2025
    Product Code
    DXC
    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
    DXC Clamp, Vascular

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXC), ordered by most recent decision date.

    Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arc Adjustable Radial Cuff Compression Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Life Saving Tourniquet

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Radial Compression Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PICOCLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all