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510(k) Data Aggregation

    K Number
    K072354
    Device Name
    GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
    Manufacturer
    ACCELLENT INC.
    Date Cleared
    2007-12-07

    (107 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCELLENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This instrument has been designed to be used with the Olympus endo-therapy Accessories. The instrument is used for the guiding and exchanging endoscopic accessories for the biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.
    Device Description
    Coated guidewire. Removal of the guidewire is not necessary during sphinctecterotomy. Three guidewire configurations, straight, V taper and angled tip. These instruments have been designed to be used with the Olympus Endo-Therapy Accessories.
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