EkoSonic內血管設備，EKOS+內血管設備
K 號：K213422 · 2021-12-14
廣告
器材摘要
EkoSonic Endovascular Device, EKOS+ Endovascular Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K213422. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EkoSonic Endovascular Device, EKOS+ Endovascular Device?
EkoSonic Endovascular Device, EKOS+ Endovascular Device is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Boston Scientific Corporation. The 510(k) number is K213422.
When did EkoSonic Endovascular Device, EKOS+ Endovascular Device receive FDA 510(k) clearance?
EkoSonic Endovascular Device, EKOS+ Endovascular Device received FDA 510(k) clearance on 2021-12-14, under 510(k) number K213422.
Who is the listed applicant for EkoSonic Endovascular Device, EKOS+ Endovascular Device?
FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for EkoSonic Endovascular Device, EKOS+ Endovascular Device?
The FDA product code for EkoSonic Endovascular Device, EKOS+ Endovascular Device is QEY.
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。
其他以 Boston Scientific Corporation 為申請人之記錄
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。
相關器械（代碼：QEY）
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。
廣告