EPi-Ease 心外膜進入裝置 (EAS)
K 號：K233959 · 2024-02-13
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器材摘要
EPi-Ease Epicardial Access Device (EAS) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-02-13 under 510(k) number K233959. 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 EPi-Ease Epicardial Access Device (EAS)?
EPi-Ease Epicardial Access Device (EAS) is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is AtriCure, Inc.. The 510(k) number is K233959.
When did EPi-Ease Epicardial Access Device (EAS) receive FDA 510(k) clearance?
EPi-Ease Epicardial Access Device (EAS) received FDA 510(k) clearance on 2024-02-13, under 510(k) number K233959.
Who is the listed applicant for EPi-Ease Epicardial Access Device (EAS)?
The FDA 510(k) record lists AtriCure, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EPi-Ease Epicardial Access Device (EAS)?
The FDA product code for EPi-Ease Epicardial Access Device (EAS) is DYB.
相關臨床試驗
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其他以 AtriCure, Inc. 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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