(90 days)
The Xpress-Way™ RX Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The Xpress-Way™ RX Extraction Catheter is not intended for use in the cerebral vasculature.
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The provided text is a 510(k) clearance letter from the FDA for the XpressWay™ RX Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria, device performance, or human studies for AI devices. It's a regulatory approval notice for a physical medical device (catheter), not an AI algorithm.
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§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).