經皮性心房顫動消融針，用於治療不可逆電子擴散下的心房顫動
PMA 核准號：P240044 · 2026-08-20
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器材摘要
Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation is the device name listed in this FDA 510(k) record. The listed applicant is Kardium, Inc.. It received FDA 510(k) clearance on 2026-08-20. The device is classified under product code QZI. It was reviewed by the CV advisory panel.
常見問題
What is the Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation?
Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Kardium, Inc..
When did Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation receive FDA 510(k) clearance?
The clearance date for Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation can be found in the official FDA records.
誰是治療心房顫動的不可逆電解術經皮心臟消融電極的登記申請人？
The FDA 510(k) record lists Kardium, Inc. as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼是什麼？針對使用不可逆電滅絕治療心房顫動的經皮心臟消融電極？
FDA產品代碼為治療心房顫動的不可逆電滅化經皮心臟消融電極的為QZI。
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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