(147 days)
The LeMaitre Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi.
Not Found
This looks like a 510(k) clearance letter from the FDA for a medical device called the "LeMaitre Embolectomy Catheter." This type of document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert details for AI/device performance evaluation.
510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While manufacturers submit data to support their claims, the detailed study information as requested is not typically included in the final clearance letter itself. These letters acknowledge the submission and state the FDA's finding of substantial equivalence.
Therefore, I cannot provide the requested information from the provided 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).