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510(k) Data Aggregation

    K Number
    K984627
    Device Name
    AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Date Cleared
    1999-07-27

    (209 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTERIAL VASCULAR ENGINEERING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.
    Device Description
    The 4F SiteSeer (II) catheter is an intravascular diagnostic catheter for use in the cardiovascular system.
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    K Number
    K983927
    Device Name
    GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Date Cleared
    1999-03-11

    (126 days)

    Product Code
    DQT
    Regulation Number
    870.1370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTERIAL VASCULAR ENGINEERING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AVE guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
    Device Description
    The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.
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    K Number
    K971295
    Device Name
    AVE BRIDGE STENT SYSTEM
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Date Cleared
    1997-11-05

    (212 days)

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

    ARTERIAL VASCULAR ENGINEERING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVE Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor. The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors. This device is not intended for intravascular use.
    Device Description
    The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ 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 AVE Bridge™ Stent System is provided enclosed in a sterile package.
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