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510(k) Data Aggregation

    K Number
    K161315
    Device Name
    Vein Clamps, Artery Clamps
    Manufacturer
    AROS Surgical Instruments Corporation
    Date Cleared
    2016-08-18

    (99 days)

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

    AROS Surgical Instruments Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgical instrument used to occlude a blood vessel temporarily.
    Device Description
    The Vein Clamps and Artery Clamps are small clamps used in surgery on small blood vessels. This Special 510(k) is being done to expand on the pressures, add a curved design, and change the sterilization process. There are no other changes and the original products cleared under K961100 remain unchanged and are still being sold.
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