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2025-10-09

智通财经APP讯，先瑞达医疗-B(06669)公布，于2025年10月7日，该集团的静脉腔内射频消融系统获得美国食品药品监督管理局的510(k)市场准入许可。本系统包括静脉腔内射频导管CedarTM及静脉腔内射频发生器，两者配合使用，用于治疗因浅静脉反流引起的下肢静脉曲张。公司已与BSC集团旗下成员公司就本产品在美国的销售签署了分销协议。未来，BSC集团将适时开始推进本产品在美国的商业化工作。

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