(53 days)
The Yasargil Titanium Aneurysm Clips presented in this submission are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.
These titanium alloy aneurysm clips will be available as temporary or permanent devices.
The provided text is a 510(k) summary for Yasargil Titanium Aneurysm Clips. This document asserts substantial equivalence to previously marketed devices and describes the product's intended use and technological characteristics. However, it does not contain any information regarding performance studies, acceptance criteria, or specific metrics typically associated with device performance evaluation.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence rather than detailed performance study results.
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).