Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101097
    Device Name
    CALGAESEAL MODEL: CAS
    Manufacturer
    Date Cleared
    2010-09-22

    (155 days)

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

    BZ MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
    Device Description
    CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized by gamma radiation to a 10°-6 SAL and used as a topical hemostasis pad. CalgaeSeal can be used alone as a wound dressing. It may be used in conjunction with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1