Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091194
    Device Name
    ALGISEAL PAD
    Date Cleared
    2009-05-18

    (25 days)

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

    EVOLUTION MEDICAL TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Algiseal Pad (calcium alginate pad alone and pad with permeable adhesive backing): Algiseal Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis patients and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, posthemostasis site dressing.
    Device Description
    Algiseal Pad - (Varying size, with and without permeable adhesive backing, packaged sterile) Pads may be used alone as a wound dressing. The Pad may also be used with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface. May be used in conjunction with a facility approved, post-hemostasis site dressing.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1