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The Surefire Spark Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire Spark Infusion System is a 0.021" lumen microcatheter with a seff-expanding tip at the distal end. The Surefire Spark serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire Spark has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels of 1.5-3.5mm. There are two radiopaque markers located at the distal end of the Surefire Spark to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The Surefire Spark Infusion System is provided sterile (EtO) for single patient use. The Surefire Infusion Systems will be available in the following sizes: Inner Diameter: 0.021 inch, Length: 120 cm, Tip / Vessel Size: 1.5 - 3.5 mm Inner Diameter: 0.021 inch, Length: 150 cm, Tip / Vessel Size: 1.5 - 3.5 mm

The Surefire Precision Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or <150um (0.025" lumen). The Surefire Precision Infusion System has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The Surefire Precision Infusion System has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. There are three radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed for re-positioning during an interventional procedure by simply retracting or advancing the inner microcatheter while holding the outer sheath stationary. When expanded, the Expandable Tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in the vessel. The Surefire Precision Infusion System is provided sterile (EtO) for single patient use.

The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. The Surefire Guiding Catheter is a single-lumen 5F catheter with a soft distal tip and a Luer-Lock hub and strain relief. The Surefire Guiding Catheter has a three-layer construction, consisting of a Teflon inner liner, metal mid-layer, and a polymer outer shaft jacket. The polymer is filled with a radiopacifier agent, to provide visibility of the catheter under fluoroscopy. The Surefire Guiding Catheter is available in 65 cm and 80 cm lengths with a variety of pre-shaped tip designs (including but not limited to Axis and Sim1) to accommodate access and positioning in a range of peripheral vascular anatomies. The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers. The Surefire Guiding Catheter is provided sterile (EtO) for single patient use.

The Surefire Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The modified Surefire Infusion System is a 0.027" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. The Surefire Infusion System has a female luer lock hub on the proximal end of the catheter and has a catheter shaft length of 150 cm. The modified Surefire Infusion System serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard 0.018" guide wires, infusion syringes, rotating hemostatic valves (RHVs/Tuohy Borsts), and embolic hydrogel particles 700um or less in size and glass microspheres 190um or less in size. The Surefire Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. The Surefire Infusion System has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 4 mm to 6 mm. The Surefire Infusion System has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. There are three radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed for re-positioning during an interventional procedure by simply retracting or advancing the inner microcatheter while holding the outer sheath stationary. When expanded, the Expandable Tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in the vessel. The Surefire Infusion System is provided sterile (EtO) for single patient use.

The Surefire Infusion System 021 is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire Infusion System 021 is a 0.021" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. The Surefire 021, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard 0.018" guide wires, infusion syringes, rotating hemostatic valves (RHVs/Tuohy Borsts), and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire 021 has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 1.5mm to 4 mm. There are two radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed up to 3 times for re-positioning an interventional procedure by simply retracting or advancing the inner microcatheter while holding the outer sheath stationary. When expanded, the Expandable Tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The Surefire Infusion System 021 is provided sterile (EtO) for single patient use.

The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. The Surefire Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy. The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking. The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers. The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

The SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER is intended for use where angiographic diagnosis is indicated.

The Surefire High Flow Angiographic Catheter (SAC) is used to facilitate advancement of the Surefire High Flow Microcatheter to the target vessel. The SAC is a single lumen, fixed length guide catheter with a Luer Lock Hub. It is compatible with standard 0.038" guide wires, Luer lock infusion syringes, and rotating hemostatic valves (RHVs). The angiographic catheter has an approximate length of 65 cm (usable length). A reinforced proximal section allows for ease of insertion and the barium sulfate filled extrusion provides clear fluoroscopic images of the shaft. A braided tungsten filled shaped tip provides visual feedback for the location of the guide catheter under fluoroscopy. The distal tip is rounded for atraumatic tracking. A shaped tip will assist to deliver the Surefire High Flow Angiographic Catheter to the desired target site. A peel-away Introducer is supplied with the SAC to insert the shaped tip into a catheter sheath introducer. The system is provided sterile (FO) for single patient use. The Angiographic Catheter is packaged in sealed sterile protective pouches and product boxes.

The Surefire® Hi-Flow Microcatheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire® Hi-Flow Microcatheter is an 0.027" lumen microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate deployment and retraction of the Surefire Expandable Tip. The infusion catheter serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard 0.018" guide wires, infusion syringes, rotating hemostatic valves (RHVs), and embolic particles 700µm or less in size. The proximal end of the device features a female luer lock hub. The microcatheter has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The outer sheath is hydrophilically coated. The usable length of the device is 120cm. The distal soft, pliable, funnel-shaped Surefire Expandable Tip is available in two tip sizes, targeted to treat vessels of 3.0 - 4.5 mm and 4.0 - 6.0 mm.

The SUREFIRE® GUIDE SHEATH is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire® Guide Sheath is designed to act as a conduit for diagnostic agents and facilitates deployment at the desired treatment location. The Guide Sheath is a 0.035" guide wire compatible, single lumen, fixed length catheter body with a luer lock hub.

The SUREFIRE™ INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire™ Infusion Catheter System is a two-part system comprised of an Infusion Microcatheter and a Guide Sheath.