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510(k) Data Aggregation

    K Number
    K220566
    Device Name
    Vascette HP (hemostatic pad)
    Manufacturer
    Date Cleared
    2022-07-29

    (151 days)

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

    KOAG LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Vascette HP is intended for use as a temporary topical dressing for the management of bleeding from vascular access sites and percutaneous catheters.
    Device Description
    Vascette HP is a 2 inch x 2 inch (50mm x 50mm) square, single use, multi-layer temporary topical wound dressing applied over vascular puncture sites and percutaneous catheter sites. There are two tissue contacting components in the device: 1) the polyethylene adhesive foam border and 2) the plant derived modified starch (carboxyl starch sodium (CMS)) hemostatic foam. The hemostatic foam is hydrophilic and dehydrates blood at the wound site, producing hemostasis. The device is non-invasive, and removal protocol is the same as other temporary topical hemostatic pads. Sterilization of the device is performed utilizing gamma irradiation to SAL 10-6.
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