主動脈瓣膜，置換瓣膜，經皮置入
PMA 核准號：P140031 · 2026-09-23
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器材摘要
Aortic valve, prosthesis, percutaneously delivered is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-09-23. The device is classified under product code NPT. It was reviewed by the CV advisory panel.
常見問題
What is the Aortic valve, prosthesis, percutaneously delivered?
Aortic valve, prosthesis, percutaneously delivered is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Edwards Lifesciences, LLC.
When did Aortic valve, prosthesis, percutaneously delivered receive FDA 510(k) clearance?
The clearance date for Aortic valve, prosthesis, percutaneously delivered can be found in the official FDA records.
Who is the listed applicant for Aortic valve, prosthesis, percutaneously delivered?
The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aortic valve, prosthesis, percutaneously delivered?
The FDA product code for Aortic valve, prosthesis, percutaneously delivered is NPT.
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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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