www.fdanews.com/articles/207398-truvic-gets-fdas-510k-clearance-for-its-prodigy-thrombectomy-system
Truvic Gets FDA’s 510(k) Clearance for its Prodigy Thrombectomy System
April 14, 2022
Campbell, Calif.-based Truvic Medical has received 510(k) clearance from the FDA for its Prodigy thrombectomy system for the removal of blood clots from inside a peripheral artery or vein.
The Prodigy system, which is the company’s first thrombectomy system to gain the FDA’s clearance, enables the removal of blood clots in a single session without the use of thrombolytics.
Truvic Medical is a subsidiary of Imperative Care, which is focused on stroke intervention and peripheral thrombectomy products.