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Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

The Medtronic Stedi™ Extra Support Guidewire (herein after referred as Stedi Guidewire) is design for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR) procedures. The Stedi Guidewire has a 0.035" diameter and is 275cm in length and composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil and the ground core are joined in two locations: a proximal bond and a distal weld. The distal end of the Stedi Guidewire is comprised of a preformed 540° curved tip is available in 2 sizes (3cm and 4cm). The Stedi Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity. The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.

SION blue PLUS is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 190cm and 300cm lengths. The guide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a 3cm radiopaque tip to achieve visibility and is available in a straight, Pre-shape and J-shape to bend with the vessel curve. A silicone and hydrophilic coatings are applied to the distal portion of SION blue PLUS. The proximal sections of the SION blue PLUS are coated with PTFE. The extension wire is connected to the end of the guide wire outside of the body for 190cm model.

This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures.

The CROSSLEAD 0.018inch is steerable guide wire with a maximum diameter of 0.46mm (0.018inches) and available in various lengths of 100 cm, 200 cm, 235 cm and 300 cm. The quide wire consists of a hybrid nitinol (Ni-Ti) and stainlesssteel (SUS) core wire with a stainless steel inner coil, a stainless steel and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A hydrophilic and polyurethane coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426). All sizes are available with a straight and a pre-shaped design.

The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures. The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.

The Prelude® Small O.D. Introducer Guide Wire is composed of a stainless-steel core wire inside a stainless-steel coil. The guide wire is welded at the distal and proximal tips and has a polished weld finish. The stainless-steel construction provides radiopacity and visibility to the user under X-ray. The wires are available in outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to 80 cm, straight and double-ended J 3mm / straight tip shapes, Standard and Firm body wire stiffness profiles, with a flexible atraumatic tip.

To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use. The guidewire is: .032" diameter and is 200cm in length. The guidewire is composed of three primary components: PTFE coating, a coil and a core. The core and coil are made of 304 stainless steel (ASTM A313). The coil is coated with low-friction polytetrafluoroethylene (PTFE). The coil provides the outer shell while the core is fit inside the inner diameter of the coil. The core provides the stiffness to the guidewire body and flexibility in the J-tip. The core and coil are secured together using a weld on both the distal and proximal of the guidewire. The guidewire is sterilized using ethylene oxide. The guidewire is loaded into a dispenser hoop and is provided with a J-straightener, which is used to aid the insertion of the delivery device. There are no accessories packaged with the guidewires.

The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures. The guide wires may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Hi-Torque Command™ 14 ST Guide Wire (guide wire with short taper) and Hi-Torque Command™ 14 MT Guide Wire (guide wire with medium taper) have a maximum diameter of 0.0144" (0.366 mm) and are provided in 210 cm and 300 cm lengths. The distal tip of the guide wire is available as a straight tip or an angled tip, both of which are shapeable.