驚濤內血管結石碎裂系統
PMA 核准號：P200039 · 2026-09-11
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器材摘要
Shockwave intravascular lithotripsy system is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2026-09-11. The device is classified under product code QMG. It was reviewed by the CV advisory panel.
常見問題
What is the Shockwave intravascular lithotripsy system?
Shockwave intravascular lithotripsy system is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Shockwave Medical, Inc..
When did Shockwave intravascular lithotripsy system receive FDA 510(k) clearance?
The clearance date for Shockwave intravascular lithotripsy system can be found in the official FDA records.
誰是列出的 Shockwave 開放性動脈內碎石系統申請人？
FDA 510(k) 記錄將 Shockwave Medical, Inc. 列為申請人。這並不單獨確立設備製造商。
什麼是 Shockwave 開放性動脈內輸尿管結石碎裂系統的 FDA 產品代碼？
FDA產品代碼為Shockwave內血管結石破碎系統的是QMG。
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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