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510(k) Data Aggregation

    K Number
    K140313
    Device Name
    STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
    Manufacturer
    COAG MEDICAL LLC
    Date Cleared
    2014-07-28

    (168 days)

    Product Code
    QSY, FRO, LYA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAG MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are intended for use as a topical dressing for the management of bleeding wounds and are available for prescription use and over-the-counter use. Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and are also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. StopsBleeding™ Rx is intended for use under the care of a health care professional. OTC: StopsBleeding™ OTC Topical Hemostat Powder and Foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
    Device Description
    The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam are sterile, topical wound dressings comprised of plant based polysaccharides that accelerate the coagulation process to form a stable clot. The hemostatic particles contained in both the powder form and the foam form accomplish this by quickening the natural drying process at the wound site and by concentrating the vital nutrients (proteins and platelets etc.) that the body uses to naturally form a clot. When more of these nutrients are present at a wound site, the body is able to accelerate the cessation of bleeding and allow the healing process to more quickly and naturally occur on its own.
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