(130 days)
The LMI Thrombectomy Catheter is intended for use in venous thrombectomy procedures for intra-operative removal of venous thrombus formations from veins.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the LMI Thrombectomy Catheter. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.
The letter is a regulatory approval document confirming market readiness based on substantial equivalence, not a detailed report of technical performance studies. Therefore, I cannot provide the requested information from the given text.
§ 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).