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The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® ACUSEAL Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: -Hernia repair as suture line reinforcement -Muscle flap reinforcement -General tissue reconstructions

The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web structure that functions as a surgical mesh for soft tissue reinforcement while providing a scaffold for tissue ingrowth. It is used to reinforce soft tissue during the phases of wound healing by filling soft tissue deficits. The device elicits a physiologic tissue response which fills the deficit with native tissue and gradually absorbs the device. The implanted GORE® BIO-A® Tissue Reinforcement is a textured porous fibrous web surface on both surfaces composed solely of synthetic bioabsorbable poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC). In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months. The GORE® BIO-A® Tissue Reinforcement is available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The device is sterilized by gamma irradiation validated to an SAL of 10°. It is for single use only.

The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.

The GORE® Tri-Lumen Catheter (TLC) is a 140cm long multi-lumen accessory catheter designed to assist with multiple wire introduction and control during endovascular procedures. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires while the two auxiliary lumens can each accommodate one 0.014" quidewire. The trailing end of the device has two distinct extension tubes to assist in the introduction of the guidewires into the auxiliary lumens. The leading end of the device is radiopaque to assist in visibility under fluoroscopy. The GORE® Tri-Lumen Catheter is designed to minimize entanglement of multiple quidewires and facilitate through and through access during cardiovascular procedures with fewer snaring maneuvers.

GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.

As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling softtissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.

The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.

The GORE® VIABIL® Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the GORE® VIABIL® Short Wire Biliary Endoprosthesis at the target site in the biliary tract. The subject of this 510(k) pre-market notification is a modification to the catheter component of the endoscopic (GI) delivery system to include a guidewire exit port located near the distal end of the catheter which will allow use of a shorter length (minimum 260cm) guidewire enabling single user control of the guidewire during use. No changes have been made to the implanted endoprosthesis of the predicate GORE® VIABIL® Biliary Endoprosthesis device.

The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

The GORE® DrySeal Flex Introducer Sheath consists of an introducer sheath with the GORE® DrySeal Valve attached, a twist style locking dilator, and a syringe. The introducer sheath is a composite tube which consists of a flat stainless steel wire reinforced hydrophilic coated Pebax® outer tube and PTFE liner with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath is attached to the GORE® DrySeal Valve. The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5 mL of saline into the space, using the provided syringe, during procedural preparation of the device. The dilator has a tapered leading end and provides dilatation of the access vessel while providing a smooth transition from the guidewire to the introducer sheath leading tip. The dilator is 0.035" guidewire compatible and has a locking mechanism which mates with, and secures to, the DrySeal Valve. The sheath hub is embossed with its French size and a visual marker on the trailing end of the dilator shaft that ensures correct combination of the dilator within the sheath.

The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® ACUSEAL Vascular Graft is a multilayer graft design comprised of expanded polytetrafluoroethylene (ePTFE) separated by an elastomeric layer and may be available both with and without covalently bound bioactive heparin on the luminal surface of the device (commonly known as the Carmeda® BioActive Surface, or CBAS® heparin). The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.

The GORE® Embolic Filter system consists of a device, a delivery catheter, and a retrieval catheter, and is compatible with guiding catheters and sheaths having a minimum inner diameter of 0.066". The GORE® Embolic Filter is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm. This Special 510(k) provides for the use of CBAS® heparin coating on the device.

The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.

The GORE® Embolic Filter system consists of a device, a delivery catheter, and a retrieval catheter, and is compatible with guiding catheters and sheaths having a minimum inner diameter of 0.066". The GORE® Embolic Filter is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.

The GORE DrySeal Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

The GORE DrySeal Sheath consists of an introducer sheath with GORE DrySeal Valve attached, a dilator, and a syringe. The introducer sheath is a polyethylene tube with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath has an insert molded hub on the trailing end, which is attached to the GORE DrySeal Valve. The GORE DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5mL of saline into the space, using the provided syringe, during procedural preparation of the device. The dilator has a tapered leading end and provides dilatation of the access vessel. A mark on the trailing end of the dilator ensures correct positioning of the dilator within the sheath.