愛德華eSheath Optima引導套件
K 號：K244046 · 2025-03-27
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器材摘要
Edwards eSheath Optima introducer set is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K244046. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Edwards eSheath Optima introducer set?
Edwards eSheath Optima introducer set is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Edwards Lifesciences. The 510(k) number is K244046.
When did Edwards eSheath Optima introducer set receive FDA 510(k) clearance?
Edwards eSheath Optima introducer set received FDA 510(k) clearance on 2025-03-27, under 510(k) number K244046.
Who is the listed applicant for Edwards eSheath Optima introducer set?
The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Edwards eSheath Optima introducer set?
The FDA product code for Edwards eSheath Optima introducer set is DYB.
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其他以 Edwards Lifesciences 為申請人之記錄
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。
相關器械（代碼：DYB）
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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