ENROUTE® 頸動脈神經保護系統
K 號：K230402 · 2023-04-11
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器材摘要
ENROUTE® Transcarotid Neuroprotection System is the device name listed in this FDA 510(k) record. The listed applicant is Silk Road Medical. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K230402. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ENROUTE® Transcarotid Neuroprotection System?
ENROUTE® Transcarotid Neuroprotection System is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Silk Road Medical. The 510(k) number is K230402.
When did ENROUTE® Transcarotid Neuroprotection System receive FDA 510(k) clearance?
ENROUTE® Transcarotid Neuroprotection System received FDA 510(k) clearance on 2023-04-11, under 510(k) number K230402.
Who is the listed applicant for ENROUTE® Transcarotid Neuroprotection System?
The FDA 510(k) record lists Silk Road Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ENROUTE® Transcarotid Neuroprotection System?
The FDA product code for ENROUTE® Transcarotid Neuroprotection System is NTE.
相關臨床試驗
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相關器械（代碼：NTE）
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。
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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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