静脉腔内射频消融系统
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先瑞达医疗-B(06669):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
智通财经网· 2025-10-09 09:22
Core Viewpoint - The company, Xianruida Medical-B (06669), 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 conjunction 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 of the BSC Group for the sales of this product in the United States [1] - The BSC Group will begin to advance 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
Zhi Tong Cai Jing· 2025-10-09 09:18
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(06669.HK):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
Ge Long Hui· 2025-10-09 09:16
Core Viewpoint - The company, Xianruida Medical-B (06669.HK), 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 an intravascular radiofrequency generator, which are used in conjunction for treatment [1] - The system is specifically aimed at addressing lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member of the BSC Group for the sales of this product in the United States [1] - The BSC Group is expected to initiate the commercialization of the product in the U.S. at an appropriate time [1]