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510(k) Data Aggregation

    K Number
    K960372
    Device Name
    SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
    Date Cleared
    1996-04-26

    (91 days)

    Product Code
    Regulation Number
    882.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANLAN INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting.
    Device Description
    The SCANLAN® Heifetz Aneurysm Elgiloy Clip System is a device used to occlude an intractanial aneurysm (a balloonlike sac formed on a blood vessel) to prevent bleeding or bursting.) The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is sold non-sterile. Descriptions of each clip size and shape are provided in the brochure. Appliers are available in five sizes and are described in the accompanying brochure (See Appendix A. ) A schematic for a representative clip size is provided in Appendix B.
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