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510(k) Data Aggregation

    K Number
    K090665
    Device Name
    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Date Cleared
    2009-05-22

    (70 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT VASCULAR-VASCULAR SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K090509
    Device Name
    FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Date Cleared
    2009-03-20

    (22 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT VASCULAR-VASCULAR SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.
    Device Description
    The FoxCross PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guide wire insertion (max 0.035''). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.
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    K Number
    K081523
    Device Name
    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Date Cleared
    2008-09-11

    (101 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT VASCULAR-VASCULAR SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emboshield® Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
    Device Description
    The Emboshield NAV6 Embolic Protection System is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: Bare Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
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    K Number
    K072708
    Device Name
    ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Date Cleared
    2008-08-18

    (328 days)

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

    ABBOTT VASCULAR-VASCULAR SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.
    Device Description
    The Absolute® Pro .035 Biliary Self-Expanding Stent System includes a selfexpanding nickel titanium stent that is pre-mounted on an over-the-wire Delivery System. A total of 12 (6 at each end) radiopaque markers made of a radiopaque nickel titanium alloy are located at the ends of the stent. The Absolute Pro .035 Biliary Self-Expanding Stent System utilizes a 0.035" (0.89 mm) guide wire. The system includes radiopaque markers that identify the stent location. The catheter comprises a retractable sheath that covers the stent during delivery. a radiopaque tip, an I-Beam to support the stent during deployment with an internal guide wire lumen, a detachable outer jacket, and a handle assembly with a safety lock and retraction features. With the handle in the unlocked position, rolling back the thumbwheel deploys the stent.
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    K Number
    K080264
    Device Name
    MODIFICATION TO: FOX PLUS PTA CATHETER
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Date Cleared
    2008-03-26

    (54 days)

    Product Code
    LIT, JAN
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT VASCULAR-VASCULAR SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.
    Device Description
    The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.
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    K Number
    K072798
    Device Name
    VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Date Cleared
    2008-01-31

    (122 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT VASCULAR-VASCULAR SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Viatrac® 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries, and carotid arties) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
    Device Description
    The Viatrac 14 PLUS Pcripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen in the distal shaft permits the use of a guide wire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral or renal guiding catheter. An additional marker is located at the guide wire exit notch and aids in locating the guide wire exit notch. The design of this catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.
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