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    K Number
    K991533
    Device Name
    MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
    Manufacturer
    PERIPHERAL AVE
    Date Cleared
    1999-07-29

    (87 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERIPHERAL AVE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic AVE Stent Delivery System - For Use In Biliary Indication device is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.
    Device Description
    The device consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. The device has two radiopaque platinum markers mounted on the stent to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035inch guidewires and has a useable length of 75cm to 120cm. The device is provided in a sterile package.
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    K Number
    K983008
    Device Name
    PERIPHERAL AVE STENT SYSTEM
    Manufacturer
    PERIPHERAL AVE
    Date Cleared
    1998-11-25

    (89 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERIPHERAL AVE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peripheral AVE Biliary Stent System is intended for use in patients who are eligible for percutaneous transluminal angioplasty (PTA) to maintain patency of a biliary duct which is occluded by tumor. The Peripheral AVE Bilairy Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors.
    Device Description
    The Peripheral AVE Bilairy Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catheter. The Peripheral AVE Bilairy Stent System has two radiopaque platinum markers imbedded in the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm to 90 cm. The Peripheral AVE Bilairy Stent System is provided enclosed in a sterile package.
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