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510(k) Data Aggregation
K Number
K090665Device 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
870.1250Why 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
K090509Device 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
870.1250Why 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
K081523Device Name
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Manufacturer
ABBOTT VASCULAR-VASCULAR SOLUTIONS
Date Cleared
2008-09-11
(101 days)
Product Code
NTE
Regulation Number
870.1250Why 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
K072708Device 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
876.5010Why 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
K080264Device 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
870.1250Why 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
K072798Device Name
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
Manufacturer
ABBOTT VASCULAR-VASCULAR SOLUTIONS
Date Cleared
2008-01-31
(122 days)
Product Code
LIT
Regulation Number
870.1250Why 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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