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510(k) Data Aggregation

    K Number
    K253070

    Validate with FDA (Live)

    Date Cleared
    2025-11-20

    (58 days)

    Product Code
    Regulation Number
    870.4450
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Namic Radial Arm Band is indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).

    Device Description

    The Namic Radial Arm Band is a tourniquet-style device consisting of a soft wristband with a secure hook and loop adjustable fastener on each end, two compression balloons, a support plate, flexible tubing with the input valve, and an inflation device. The device is offered in two lengths, 23 cm and 26 cm.

    The use of the Namic Radial Arm Band begins after the transradial catheterization procedure is concluded and as the introducer sheath is gradually withdrawn from the patient. The wristband is placed around the patient's wrist with the adjustable hook and loop fastener. Once the Radial Arm Band is secured in place, the inflation device is connected via the input valve and tubing. The inflation device is used to apply pressure to the patient's access site. Both radial compression balloons (RCB) are filled with air at the same time to allow for efficient compression for hemostasis. The volume of air can be increased or decreased using the inflation device, thus allowing the physician to adjust the pressure in the Radial Arm Band. The Namic Radial Arm Band is a disposable, single use only device.

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