(28 days)
The Atlantis™ SR Pro 2 Coronary Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
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The provided text is a 510(k) summary for the Boston Scientific Atlantis™ SR Pro 2 Coronary Imaging Catheter. It does not contain information about acceptance criteria, device performance, specifics of a study proving those criteria, ground truth establishment, or human-in-the-loop performance. It primarily focuses on regulatory information, such as predicate devices, classification, and indications for use.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory filing, not a scientific study report describing performance metrics or validation methodologies.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).