針對支架定位輔助系統（SPAS）的醫療設備規範文本翻譯： 針對支架定位輔助系統（SPAS）的醫療設備規範文本
K 號：K221917 · 2022-08-19
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器材摘要
Stent Positioning Assistance System (SPAS) is the device name listed in this FDA 510(k) record. The listed applicant is Seven Sons , Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K221917. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Stent Positioning Assistance System (SPAS)?
Stent Positioning Assistance System (SPAS) is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Seven Sons , Ltd.. The 510(k) number is K221917.
When did Stent Positioning Assistance System (SPAS) receive FDA 510(k) clearance?
Stent Positioning Assistance System (SPAS) received FDA 510(k) clearance on 2022-08-19, under 510(k) number K221917.
Who is the listed applicant for Stent Positioning Assistance System (SPAS)?
The FDA 510(k) record lists Seven Sons , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stent Positioning Assistance System (SPAS)?
The FDA product code for Stent Positioning Assistance System (SPAS) is DQX.
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相關器械（代碼：DQX）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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