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510(k) Data Aggregation

    K Number
    K190975
    Device Name
    Plexus SCD110 Sequential Compression Device Sleeve
    Date Cleared
    2019-07-22

    (98 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Midway Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Plexus SCD 110 DVT Sleeve is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, obstetric conditions and treatments.
    Device Description
    The Plexus SCD110 Sequential Compression Device is a non-sterile sequential compression sleeve intended to be used with commercially-available compression pumps*. The device is used to prevent the onset of deep vein thrombosis (DVT) by stimulating blood flow and increasing venous flow velocity. The device consists of a pair of soft pressure garment sleeves with an internal air bladder. Each package of Plexus SCD110 has two compression sleeves – one for the right calf and one for the left calf. The Plexus SCD110 is a single-bladder sleeve that provides a preset pattern of intermittent pressure to the deep vein in the lower leg. To use the device, the garment sleeve is wrapped around a patient's calf. The compression sleeve is connected to a commercially available DVT compression pump intended to be used with single-chamber air bladder sleeves. The connector of the sleeve is designed such that it will not connect to a pump intended for multi-chamber sleeves. When the compression pump is turned on, air flows from the air pump into the air bladder inside the compression sleeve, providing pneumatic pressure on the calf muscle and veins underneath. Once the compression pump reaches an air pressure of 40 mmHg), a relief valve is triggered within the DVT pump to let air escape from the sleeve and reduces the pressure within the system. With the relief valve opened, the compression sleeve completely deflates and allows blood to re-enter the deep veins of the patient during this cycle. After a pre-set deflation period (~50-second cycle), the relief valve will close and the air pump will start pumping again to 40 mmHg. This cycle of inflation of the air bladder will continue until the compression pump device is turned off. The Plexus SCD110 sleeve is made of a soft, lightweight, non-woven foam-felt material with a singlechamber bladder made of polyvinyl chloride (PVC). The Plexus SCD sleeve is intended to be compatible with single-chamber DVT pump systems only and the connectors will not allow the sleeve to be attached to any other compression systems (i.e. multi-chamber DVT systems, lymphedema compression systems)
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