(119 days)
The EkoSonice Endovascular System is indicated for the ultrasound facilitated, controlled and selective infusion of physicianspecified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
Not Found
I apologize, but the provided text does not contain information about the acceptance criteria, device performance, or any study details. The documents are standard FDA 510(k) clearance letters for the EkoSonic Endovascular System, primarily focused on administrative changes, regulatory classification, and indications for use. There is no information in these documents about how the device meets acceptance criteria or details of a study proving its performance.
§ 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).