三鑫醫療(300453.SZ):PTA高壓球囊擴張導管獲得醫療器械註冊證
格隆匯8月3日丨三鑫醫療(300453.SZ)公佈,公司於近日取得了國家藥品監督管理局頒發的《醫療器械註冊證》,產品名稱為PTA高壓球囊擴張導管,該產品適用於外周血管系統(如髂動脈、股動脈、膕動脈、膝下動脈、鎖骨下動脈以及腎動脈等)的經皮腔內血管成形術(PTA),並適用於治療自體或人造透析用動靜脈痿的堵塞病變。
公司本次獲得醫療器械註冊證的PTA高壓球囊擴張導管由球囊、標記環、導管、導管加強件、導管座、球囊護套和抗折套管組成。球囊材料為聚酰胺(PA)。經環氧乙烷滅菌,一次性使用。該產品可以針對性地解決患者痛點問題,廣泛運用於血液淨化治療、腎內科、介入科等,市場空間廣闊。
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