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The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The NES Reprocessed Visions 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 NES Reprocessed Visions PV .018 Digital IVUS Catheter utilizes a cylindrical ultrasound transducer array close to the distal tip to radiate acoustic energy into the surrounding tissue. By using the information gathered from the ultrasonic echoes, the device can generate real-time images of the coronary and peripheral vessels. The NES Reprocessed Visions PV .018 Digital IVUS Catheter tracks over a 0.018" (0.46mm) guide wire by through an internal lumen. Approximately 31 cm from the catheter tip is a guidewire port for the exiting guidewire. The NES Reprocessed Visions PV .018 Digital IVUS Catheter is introduced into the vascular system percutaneously or via surgical cutdown. The NES Reprocessed Visions PV .018 Digital IVUS Catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. If connect to another system, the catheter will not operate. The NES Reprocessed Visions PV .018 Digital IVUS Catheter is intended to be reprocessed one (1x) time.

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The NES Reprocessed Eagle Eye Platinum RX 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 NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array 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 coronary and peripheral vessels. The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter is introduced percutaneously or via surgical cutdown into the vascular system. Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the scanner marker tube normally visible under fluoroscopy. The Eagle Eye catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system. A hydrophilic coating is applied externally to a distal portion of the catheter.

The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014" guidewire compatible and over-the-wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. The 0.014" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nutinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

The NES Reprocessed Spectranetics Turbo-Elite Laser Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen. Catheter sizing identification is printed on the catheters. For NES Reprocessed Spectranetics Turbo-Elite Laser Catheters, Over-The-Wire (OTW) catheters, a Luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriately sized guidewire.

The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The NES Reprocessed .014P RX 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 NES Reprocessed Visions PV .014P RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array 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 coronary and peripheral vessels. The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cutdown into the vascular system. Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the scanner marker tube normally visible under fluoroscopy. The VISIONS PV .014P catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system. A hydrophilic coating is applied externally to a distal portion of the catheter.

The NES Reprocessed RF Stylet (RFS) is intended for use in vessel and tissue coagulation including: - Treatment of incompetent (i.e. refluxing) perforator and tributaiy veins.

The NES Reprocessed RF Stylet (RFS) is a reprocessed VNUS RFS (510(k) # K052003). The device is a high frequency electrosurgical system designed for blood vessel and tissue coagulation in general surgical procedures. This device's energy source comes from a compatible and separately cleared Radiofrequency (RF) Generator. The device has been validated to be reprocessed a maximum of one time. The NES Reprocessed RF Stylet (RFS) is provided sterile (EtO) and is a single use, disposable device. The device is used in a healthcare facility. The device's function is to deliver RF energy to the desired treatment site and relay temperature and other information to the RF Generator. The device consists of one model. The device itself consists of the stylet shaft, handle and cable. A sharp is included with the device for patient insertion. The tip of the stylet serves to deliver the RF energy to the desired treatment site while the cable plugs into the RF generator (for power and relay temperature/other feedback). The tip, inner and outer lumen are the only patient-contacting parts. The patient-contacting material is as follows: AISI 304 SST and polyimide. All patient-contacting material has proven to be biocompatible. The non patient-contacting material is as follows: poly methyl methacrylate and polypropylene. The device is compatible with the separately cleared Radiofrequency (RF) Generator. The NES Reprocessed RF Stylet (RFS) is considered an external communicating device with circulating blood contact for a duration of less than 24 hours.

The NES Reprocessed Varicose Vein RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

NES Reprocessed Varicose Vein RF Catheters are specially designed electrosurgical catheters. RF (radiofrequency) energy is delivered to an intravascular catheter in order to heat a blood vessel to a predetermined heat and coagulate that blood vessel. NES Reprocessed Varicose Vein RF Catheters incorporate a hand piece, a flexible shaft and a distal tip section containing the RF (radiofrequency) electrode.

Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Trocars are devices inserted into a patient in order to maintain a clear pathway to facilitate the insertion of various surgical tools. Trocars are designed in both bladed and non-bladed configurations, however this submission is for non-bladed B5LTs. Non-bladed trocars require an incision be made before insertion into the patient's cavity. Trocars have a luer stopcock port for insufflation and desufflation of the patient's cavity. NES Reprocessed Endoscopic Trocars are sent from a user facility to be cleaned, sterilized and repackaged by NES. NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM).