LAA排除系統
K 號：K232295 · 2023-08-30
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器材摘要
LAA Exclusion System is the device name listed in this FDA 510(k) record. The listed applicant is Syntheon, LLC. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K232295. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LAA Exclusion System?
LAA Exclusion System is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Syntheon, LLC. The 510(k) number is K232295.
When did LAA Exclusion System receive FDA 510(k) clearance?
LAA Exclusion System received FDA 510(k) clearance on 2023-08-30, under 510(k) number K232295.
Who is the listed applicant for LAA Exclusion System?
The FDA 510(k) record lists Syntheon, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LAA Exclusion System?
The FDA product code for LAA Exclusion System is PZX.
相關臨床試驗
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相關器械（代碼：PZX）
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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