(91 days)
The EkoSonic Endovascular System is indicated for the:
- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- Infusion of solutions into the pulmonary arteries.
- Controlled and selective infusion of physician-specified fluids, into the peripheral vasculature.
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This document is a 510(k) clearance letter for the EkoSonic MACH 4 Endovascular Device with EkoSonic Control Unit. It primarily focuses on the regulatory aspects and indications for use, and does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information from the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the performance evaluation of the device.
§ 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).