心导管，經皮，心臟消融，用於治療心房顫動
PMA 核准號：P210027 · 2026-09-15
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器材摘要
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2026-09-15. The device is classified under product code OAE. It was reviewed by the CV advisory panel.
常見問題
What is the Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation?
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Biosense Webster, Inc..
When did Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation receive FDA 510(k) clearance?
The clearance date for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation can be found in the official FDA records.
誰是針對治療心房顫動的經皮心臟消融導管之登記申請人？
The FDA 510(k) record lists Biosense Webster, Inc. as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為Catheter, percutaneous, cardiac ablation, 用於治療心房顫動的經皮心臟消融導管是什麼？
FDA產品代碼，針對經皮心臟消融治療心房顫動的導管為OAE。
相關臨床試驗
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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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