愛德華eSheath導入套件
K 號：K200258 · 2020-03-09
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器材摘要
Edwards eSheath 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 2020-03-09 under 510(k) number K200258. 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 Introducer Set?
Edwards eSheath Introducer Set is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Edwards Lifesciences. The 510(k) number is K200258.
When did Edwards eSheath Introducer Set receive FDA 510(k) clearance?
Edwards eSheath Introducer Set received FDA 510(k) clearance on 2020-03-09, under 510(k) number K200258.
Who is the listed applicant for Edwards eSheath 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 Introducer Set?
The FDA product code for Edwards eSheath 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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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