AcQGuide® VUE 經營導管
K 號：K221044 · 2022-05-05
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器材摘要
AcQGuide® VUE Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221044. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AcQGuide® VUE Steerable Sheath?
AcQGuide® VUE Steerable Sheath is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K221044.
When did AcQGuide® VUE Steerable Sheath receive FDA 510(k) clearance?
AcQGuide® VUE Steerable Sheath received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221044.
Who is the listed applicant for AcQGuide® VUE Steerable Sheath?
The FDA 510(k) record lists Acutus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AcQGuide® VUE Steerable Sheath?
The FDA product code for AcQGuide® VUE Steerable Sheath is DRA.
相關臨床試驗
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其他以 Acutus Medical, 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：DRA）
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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