NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
Northeast Scientific, Inc.The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a medical device designed to image the inside of coronary and peripheral blood vessels using ultrasound. It provides real-time cross-sectional images to help clinicians evaluate vessel morphology as an adjunct to angiography, aiding in diagnosis and treatment planning for cardiovascular conditions.
Intended Use
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; not indicated for cerebral vessels; used as adjunct to angiography to provide images of vessel lumen and wall structures.
Technology
Utilizes a cylindrical ultrasound transducer array near the distal tip to emit acoustic energy and gather ultrasonic echoes, enabling real-time imaging of coronary and peripheral vessels; tracks over a 0.018 inch guide wire via internal lumen; designed to be compatible with specific Volcano s5 or CORE Systems; reprocessed device with same design and operation as predicate.
Performance
Bench and laboratory testing included cleaning, sterilization validation, and functional tests such as visual inspection, dimensional verification, simulated use, mechanical characteristics, system compatibility, image acuity, transducer acoustic output and thermal testing, flushing adapter compatibility, surface property, drying, packaging, and biocompatibility testing. The device is reprocessed only once and marking during reprocessing tracks usage to ensure safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/27/2025
2 months - 2
FDA Approval
5/12/2025
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