Core Viewpoint - The company has received FDA 510(k) market clearance for its intravascular radiofrequency ablation system, which is designed to treat lower limb varicose veins caused by superficial venous reflux [1] Group 1: Product Details - The intravascular radiofrequency ablation system includes the CedarTM intravascular radiofrequency catheter and the intravascular radiofrequency generator, which are used in combination for treatment [1] - The system targets lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member company of the BSC Group for the sales of this product in the United States [1] - The BSC Group will initiate the commercialization of the product in the U.S. at an appropriate time [1]
先瑞达医疗-B：静脉腔内射频消融系统取得美国食品药品监督管理局510(K)市场准入许可