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The Atrium (Wrapped) Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.

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The ePTFE Ringed GORE-TEX® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The ePTFE Ringed GPRE-TEX® Vascular Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft base tube with ePTFE reinforcing film and optional manufacturing modifications. The proposed modifications consist of replacing external, semi-rigid reinforcing rings of fluorinated ethylene propylene (FEP) with rings created within the graft wall of the ePTFE. These ring structures alternate with a typical graft structure the entire length of the graft. Additionally, small gold dots may be placed at intervals anywhere along the graft, in conjunction with, or as an alternative to the blue orientation markers. The proposed modifications do not present new issues of safety and effectiveness compared to predicate vascular grafts.

The Atrium Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ Graft use in aortocronary bypass applications or for use as a patch.

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The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only. - Thinwall Perma-Pass Grafts are not indicated for blood access. . - Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.

The Perma-Pass™ Vascular Graft is manufactured from the following materials; polytetraflouroethylene (PTFE) resin, lubricant used as a manufacturing aid, and a black pigment used to create the orientation line. These grafts are available in a straight configuration with an internal diameter of 5mm, thin wall, and lengths sufficient to satisfy most vascular graft applications. The Perma-Pass Graft is constructed from the same materials used in manufacturing the tubing for the Perma-Flow® Coronary Bypass Graft, manufactured by Possis Medical, Inc. and approved under HDE H970005 dated 30 April, 1998. These grafts are supplied in the same packaging as the Perma-Flow Graft and are packaged, labeled and sterilized in the same manner.

Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.

The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

The IMPRA ePTFE Arteriovenous Cuffed Graft is indicated for use as a subcutaneous arteriovenous conduit for blood access.

The IMPRA ePTFE Arteriovenous Cuffed Graft is an expanded polytetrafluoroethylene angioaccess graft [i.e., an IMPRA ePTFE Vascular Graft, the predicate device for this 510(k)] with a modified venous end. The venous end is cuffed, facilitating vessel conformity, a uniform suturing surface, and improved flow through the anastomosis. The IMPRA ePTFE Arteriovenous Cuffed Graft is made from the same materials as the predicate device, i.e., polytetrafluoroethylene (PTFE), lubricant used as a manufacturing aid, a blue pigment used in the orientation lines, and the external support PTFE beading. These grafts are supplied in the same product configurations as the predicate device (straight, stepped, CenterFlex, and stepped CenterFlex), and are packaged, labeled, and sterilized in the same manner as the predicate device.

The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.