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The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media. The balloon provides temporary vascular occlusion during these procedures. The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.

The Branchor X Balloon Guide Catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of the balloon guide catheter and recommended balloon injection volume are provided on the product label. The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section. This allows the guidewire and other devices to easily move through the section. The Branchor X Balloon Guide Catheter is packaged with a luer-activated valve, a syringe, a three-way stopcock, a rotating hemostasis valve (RHV), and a peel-away accessories.

The FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media. The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.

The FUBUKI XF-R Neurovascular Long Sheath (FUBUKI XF-R) consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft. The subject device is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures. The outer surface of the long sheath is coated with a hydrophilic polymer and the inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the guidewire and other devices. The dilator consists of two parts: (1) a shaft and (2) a connector. The FUBUKI XF-R is supplied with a dilator and rotating hemostasis valve (RHV) packed in a sterile package.

This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

The CHIKAI Nexus 014 consists of a stainless-steel tapered core wire, with an inner coil and outer coil made of radiopaque Pt-Ni alloy and stainless-steel. Surrounding the inner coil and the distal core wire is a radiopaque Pt-Ni alloy and stainless-steel outer coil. The radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy. Outer and inner coils are soldered to the tapered core wire with Ag-Sn solder. A similar coil design is used with other ASAHI guide wires, such as the predicate CHIKAI black (K141751). Additionally, the CHIKAI Nexus 014 employs hydrophilic, polyurethane, PTFE, and silicone coatings which are used in the predicate and reference devices. The nominal outer diameter of the CHIKAI Nexus 014 is 0.36 mm (0.014 inch). The device is available in two lengths: 215 cm and 300 cm. Both sizes are available with straight, pre-shape, and angled designs.

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.

This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.

The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.

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 Tracker is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 100cm, 200cm, 235cm and 300cm length. This Guide Wire consists of a hybrid Ni-Ti and stainless-steel core wire with a Pt-Ni inner coil and Pt-Ni and stainless-steel outer coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity 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 material of the CROSSLEAD Tracker are similar to that previously described in the predicate Regalia XS 1.0 (K083146/K163426) and reference devices MINAMO (K190176), ASAHI Gaia Next(K192599) and ASAHI Gladius (K150445/K163426).

This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.

The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 Microcatheters are sterile single use devices designed for use in the peripheral vasculature. The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 consist of a catheter shaft that is reinforced with braid wires to enhance pushability and maintain patency of the inner lumen. A radiopaque marker is fixed on the distal end of the catheter shaft to facilitate location of the catheter during angiography. The distal portion of the catheter shaft is flexible and available in two shapes, straight and angled, to provide improved trackability in tortuous vessels. A hydrophilic coating is applied on the outer surface of the catheter to provide a smooth transition. In addition, accessories, including either a stylet, syringe and RHV (rotating hemostasis valve), or a stylet, syringe, inserter and hemostasis valve are available for use with the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3.