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510(k) Data Aggregation

    K Number
    K980002
    Device Name
    KOALA VASCULAR CLAMPS AND INSERTS
    Date Cleared
    1998-06-18

    (167 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSS INSTRUMENTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.
    Device Description
    The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.
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