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510(k) Data Aggregation

    K Number
    K981645
    Device Name
    TITANIUM HEMOSTATIC CLIP
    Manufacturer
    VITALITEC INT'L., INC.
    Date Cleared
    1998-10-13

    (158 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALITEC INT'L., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VITALITEC INTERNATIONAL, INC. Hemostatic Clip is designed for the intended use of figure occlusion of vessels and prevent any slippage once applica. The clip masters is required or radiographic marking is necessary. Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The clip can be left in vivo without sequela as it is biologically inert.
    Device Description
    The clips are composed exclusively of titanium and are supplied sterile in various sizes (mini-micro, micro, small/medium, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and International Organization Standard , ISO 5832-2-93 "Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium".
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