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The Endologix AFX Introducer System is intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

The Endologix AFX Introducer System, Model S17-45 consists of an Introducer Sheath (45cm working length), Dilator, and a peel-away wire straightener. The AFX Introducer System is a single-use sterile device that is compatible with a standard 0.035" guidewire.

The Endologix AFX Introducer Systems are intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

The Endologix AFX Introducer Systems consist of an Introducer Sheath (45 cm working length) and either one or two Dilators. Model S17-45DD contains dual dilators: a dual-lumen dilator for introduction and management of two guidewires; and, a single-lumen dilator. Model S17-45 contains only the single-lumen dilator. Each AFX Introducer System is enclosed in a sterile package. Each system is compatible with a standard 0.035" guidewire. - Introducer Sheath: The Introducer Sheath provides a conduit for introducing other interventional devices, including guidewires and interventional catheters, into the vasculature. The main components of this assembly are a hydrophilically-coated, PTFE lined, 55D Pebax introducer sheath, acrylobutylstyrene (ABS) hemostasis valve housing with butyl rubber valve, and silicone gasket assembly, 3 way stopcock/valve, and sideport diethylhexyl phthalate (DEHP)-free polyvinylchloride (PVC) tubing. The Pebax introducer sheath also includes an embedded stainless steel braid for increased strength and kink resistance, and embedded Vectrands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium. There are no changes to the Introducer Sheath from that cleared under K110090. - Dilators: The dilators for these systems are used to provide support and stability to the Introducer Sheath during deployment into the vasculature. The dilators are designed specifically for the Endologix AFX Introducer Systems and can accommodate a 0.035" guidewire through the central lumen. One dilator is a single lumen device and the other dilator is a dual lumen device. Both dilators are composed of 63D Pebax with 30% Barium Sulfate (BaSO4) for radiopacity and include a hydrophilic coating on the outer surface. These dilators are designed in diameter and length to be placed within the AFX Introducer Sheath component. The dilators have a tapered, atraumatic distal tip. The proximal end of the dilators includes a luer port. The dilators provide stiffness to the assembly so that the introducer sheath can be placed within the vasculature during standard vascular access. There are no changes to the Dilators from that cleared under K110090. Model S17-45 contains only the single lumen dilator; Model S17-45DD contains both dilators with the AFX Introducer System within the package.

The AFX Introducer System facilitates the introduction of guidewires, and other medical devices into the vasculature and minimizes blood loss associated with such introduction.

The Endologix AFX Introducer System consists of an Introducer Sheath (45 cm working length) and two Dilators. The system is enclosed in a sterile package. During clinical use, the system will allow introduction of a standard 0.035" guidewire within its inner lumen. Introducer Sheath: The Introducer Sheath provides a conduit for introducing other interventional devices, including guidewires and interventional catheters, into the vasculature. The main components of this assembly are a hydrophilically-coated, PTFE lined, 55D Pebax introducer sheath, acrylobutylstyrene (ABS) hemostasis valve housing with butyl rubber valve, and silicone gasket assembly, 3 way stopcock/valve, and sideport diethylhexyl phthalate (DEHP)-free polyvinylchloride (PVC) tubing. The Pebax introducer sheath also includes an embedded stainless steel braid for increased strength and kink resistance, and embedded Vectran® strands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium. Dilators: The dilators for the system are used to provide support and stability to the Introducer Sheath during deployment into the vasculature. The dilators are designed specifically for the Endologix AFX Introducer System and can accommodate a 0.035" guidewire through the central lumen. Two dilators are included with the AFX Introducer System. Both dilators are included within the package. One dilator is a single lumen device and one dilator is a dual lumen device. Both dilators are composed of 63D Pebax with 20% Barium Sulfate (BaSO4) for radiopacity and include a hydrophilic coating on the outer surface. These dilators are designed in diameter and length to be placed within the AFX Introducer Sheath component. The dilators have a tapered, atraumatic distal tip. The proximal end of the dilators includes a luer port. The dilators provide stiffness to the assembly so that the introducer sheath can be placed within the vasculature during a standard vascular access.

For use during a two guidewire procedure

The Visifiex Dual Lumen Catheter is designed to allow for the insertion of two guidewires into a single vessel, preventing them from crossing or entangling, and then allowing them to separately advance into different vessels. The Visifiex Dual Lumen Catheter consists of two lumens: one lumen allows the guidewire to advance along its length, and the second lumen allows separation and release of the second guidewire via two skives located 35cm apart and peeling along its length. There is a radiopaque marker near the tip of the catheter to provide visibility when placing the Visifiex Dual Lumen Catheter. There is also a radiopaque marker located at the proximal skive to aid in positioning of the catheter for advancement of a guidewire. The Visifiex Dual Lumen Catheter has an orientation feature that provides for proper positioning to aid in guidewire placement. The Visifiex Dual Lumen Catheter has a working length of 90cm and is compatible with a 9Fr introducer sheath. The proximal end of the catheter consists of a female luer connector.

For use during a two guidewire procedure

Dual Lumen Catheter