心外膜進入系統
K 號：K213582 · 2022-06-30
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器材摘要
Epicardial Access System is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K213582. 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 Epicardial Access System?
Epicardial Access System is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K213582.
When did Epicardial Access System receive FDA 510(k) clearance?
Epicardial Access System received FDA 510(k) clearance on 2022-06-30, under 510(k) number K213582.
Who is the listed applicant for Epicardial Access System?
The FDA 510(k) record lists Baylis Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Epicardial Access System?
The FDA product code for Epicardial Access System is DYB.
相關臨床試驗
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其他以 Baylis Medical Company, 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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