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510(k) Data Aggregation

    K Number
    K974617
    Device Name
    PERIPHERAL VASCULAR DILATOR
    Date Cleared
    1998-12-01

    (355 days)

    Product Code
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOVASCULAR INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.
    Device Description
    The vascular dilator is a catheter with smooth stainless steel tip(s) that enlarges the lumen of the artery and/or measures the caliber via the tip of the vessel. Access is either percutaneous (interventional through a sheath) or cut down (surgical, through an ateriotomy) procedure. The vascular dilator is used over a guidewire and has tip(s) of increasing size to enlarge the lumen with each repeated pass or to measure the vessel size. Only an appropriately trained physician using sterile techniques uses the sterile device.
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