LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971588
    Device Name
    EVI SUTURED-CLIP APPLIER
    Manufacturer
    ELECTIVE VASCULAR INTERVENTION INC. (EVI)
    Date Cleared
    1997-10-24

    (176 days)

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

    ELECTIVE VASCULAR INTERVENTION INC. (EVI)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elective Vascular Intervention (EVI) Sutured-Clip™ and Sutured-Clip Applier™ are intended for endoscopic and non-endoscopic use in the creation of everting anastomoses in blood vessels, grafts and other tubular structures.
    Device Description
    The Elective Vascular Intervention (EVI) Sutured-Clip™ and Clip Applier is a single fire applier that applies EVI Sutured-Clips™ for vascular anastomsis and tissue approximation applications. The Sutured-Clip consists of a vascular clip with a needle swaged or connected to one end. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
    Ask a Question

    Page 1 of 1