(120 days)
The Millar Angiographic catheter is designed to provide high fidelity pressure readings and deliver radiopaque contrast medium to selected sites in the vascular system.
Not Found
This document is a 510(k) clearance letter for the Mikro-Tip Angiographic Catheter and does not contain the detailed study information requested. The letter states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the information requested in the prompt based on the provided document. The document only confirms the FDA clearance for the device and its intended use, but it does not include details on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
§ 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).