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ViewFlex™ Xtra ICE Catheter The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac, structures, blood flow and other devices within the heart. ViewFlex™ Eco Reprocessed ICE Catheter The ViewFlex™ Eco Reprocessed Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart. Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ The Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. Agilis™ NxT Steerable Introducer The Agilis™ NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias. Agilis™ NxT Steerable Introducer Dual-Reach™ The Agilis™ NxT Steerable Introducer Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™ is a sterile, single-use device that con-sists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter intro-duction and/or exchange. It has a sideport with three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The ViewFlex™ X ICE Catheter Sensor Enabled™ is indicated for use in adult and adolescent pediatric patients for intra-cardiac and intra-luminal visualization of cardiac and great vessels anatomy and physiology, as well as visualization of other devices in the heart. When used with a compatible three-dimensional mapping system, the catheter provides location information.

The ViewFlex™ X ICE Catheter Sensor Enabled™ (SE) is a sterile, single use, temporary, radiopaque, intracardiac ultrasound catheter. The catheter shaft is a 9 French (F) catheter constructed with flexible tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64‑element linear phased array transducer. The distal portion of the shaft is deflectable utilizing two handle mechanisms which create four deflection directions including left, right, anterior and posterior. The distal tip contains an ultrasound transducer and 3-D location sensor providing 2-D imaging and 3-D location and orientation information when used with a compatible ultrasound system and the EnSite X Cardiac Mapping System.

The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the distal tip. The dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.

The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

The MitraClip G5 Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum. The TriClip G5 Steerable Guide Catheter is used for introducing various catheters into the right side of the heart.

The MitraClip G5 Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The device provides a conduit to access the left atrium. The SGC's primary function is to dilate the atrial septum, maneuver to the target location above the mitral valve, and position the CDS. The MitraClip G5 Steerable Guide Catheter is provided sterile and for single use only. The TriClip G5 Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The TriClip G5 Steerable Guide Catheter is provided sterile and for single use only. The MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are equivalent in terms of design, material, principle of operation, and sterilization method. There are minor differences in design to facilitate access to different areas of the heart.

The Agilis NxT Steerable Introducer Dual-Reach is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

The Agilis™ NxT Steerable Introducer Dual-Reach™™ is a sterile, single-use device that consists of a dilator and steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The inner diameter of the steerable introducer is 13F. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. It has a sideport with a three-way stopcock for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥180° and counterclockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

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.

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the right side of the heart.

The TriClip Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The distal shaft is steered using a handle and knobs. The TriClip Steerable Guide Catheter is compatible with devices (e.g., catheters) with a maximum diameter of 5.2 mm (0.204"), and the Dilator is compatible with devices (e.g., needles or guidewires) with a maximum diameter of 0.9 mm (0.035"). The TriClip Steerable Guide Catheter consists of materials including nylon, stainless steel, polycarbonate, PVP coating, silicone, urethane, PVC, and Pebax. The distal shaft has a hydrophilic coating to provide a lubricated surface for ease of insertion. The TriClip Steerable Guide Catheter is provided EO sterile and for single use only.