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510(k) Data Aggregation

    K Number
    K053398
    Device Name
    COMPASS COMPRESSION ASSIST HANDLE
    Manufacturer
    SEMLER TECHNOLOGIES, INC. DBA
    Date Cleared
    2006-03-10

    (94 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEMLER TECHNOLOGIES, INC. DBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use to provide hemostasis of the femoral vascular access site following catheterization or cannulation procedures.
    Device Description
    This device is similar to the EZ Hold handle. The Compass device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. A sterile SuperComfort disc is affixed to the handle. Then the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis. Use of the handle and disc by a medical practitioner avoids prolonged direct contact with bodily fluids, and alleviates bio-mechanical stress which may occur during traditional direct digital compression of the femoral artery post-cardiac catheterization. The handle and disc provide a mechanical means for a medical practitioner to hold external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis on the access site or at a pressure point. Unlike the predicate device, the Compass handle mates with the SuperComfort™ Disc. The predicate device is made of stainless steel; the Compass handle is made of polycarbonate.
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