(96 days)
The Reliant Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
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The provided text is a 510(k) summary for the Reliant Stent Graft Balloon Catheter. It outlines the device's intended use, classification, and predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
This document primarily serves to demonstrate substantial equivalence to previously cleared devices based on intended use, overall catheter configuration, and performance characteristics (which are assumed to be similar to the predicates but not detailed in this summary).
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about related studies based only on the provided text. This information would typically be found in more comprehensive testing summaries or clinical trial reports submitted as part of the 510(k) application, but it is not present in this specific summary document.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).