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The VeriSight/VeriSight Pro ICE catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm. The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide. The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

The VeriSight VeriSight Pro ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Intracardiac Echocardiography (ICE) System comprises of the VeriSight Pro ICE Catheters, the ICE PIM, and the EPIQ Diagnostic Ultrasound System (cleared under K202216). The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm. The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide. The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

The Reconnaissance PV .018 Digital IVUS catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicted for use in cerebral vessels. The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reconnaissance PV .018 OTW IVUS Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end and has a transducer that utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The Reconnaissance PV .018 Digital IVUS catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The catheter has 150cm working length and a hydrophilic coating at the distal 40 cm to assist the clinician in advancing the catheter to the desired location. The minimum guide sheath is 5F (0.074") and the maximum guide wire Outer Diameter (OD) is 0.018" (0.46 mm). At the proximal end, there is a PIM Connector and Y Connector (aka Y-Arm). The Y-Arm allows the catheter to incorporate the PIM Connector while still serving as an over-the-wire design. A Luer/hub fitting (aka the Y-Arm) is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the scanner lead wires, routed from the cylindrical ultrasound transducer array, to interface electrically with the patient interface module (PIM) connector. The Visions® PV 0.018 Catheter may only be used with Philips Imaging Systems, such as the CORE Series Precision Guided Therapy Systems such as the IntraSight System.