EKOS PE內血管設備搭配控制系統4.0（CS4.0）
K 號：K200648 · 2020-08-17
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器材摘要
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ekos Corporation. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K200648. 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 EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Ekos Corporation. The 510(k) number is K200648.
When did EKOS PE Endovascular Device with Control System 4.0 (CS4.0) receive FDA 510(k) clearance?
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) received FDA 510(k) clearance on 2020-08-17, under 510(k) number K200648.
Who is the listed applicant for EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?
The FDA 510(k) record lists Ekos Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?
The FDA product code for EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is QEY.
相關臨床試驗
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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。
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