經心臟隔膜閉塞器（心房）
PMA 核准號：P200032 · 2026-06-05
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器材摘要
Transcatheter septal occluder (atrial) is the device name listed in this FDA 510(k) record. The listed applicant is Occlutech Holding AG. It received FDA 510(k) clearance on 2026-06-05. The device is classified under product code OZG. It was reviewed by the CV advisory panel.
常見問題
What is the Transcatheter septal occluder (atrial)?
Transcatheter septal occluder (atrial) is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Occlutech Holding AG.
When did Transcatheter septal occluder (atrial) receive FDA 510(k) clearance?
The clearance date for Transcatheter septal occluder (atrial) can be found in the official FDA records.
Who is the listed applicant for Transcatheter septal occluder (atrial)?
The FDA 510(k) record lists Occlutech Holding AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Transcatheter septal occluder (atrial)?
The FDA product code for Transcatheter septal occluder (atrial) is OZG.
相關臨床試驗
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。
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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