FDA 510(k)

Sentinel 腦部保護系統

K 號：K192460 · 2020-02-19

決定日期2020-02-19

產品代碼PUM

諮詢委員會履歷

決定相當於

器材摘要

Sentinel Cerebral Protection System 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 2020-02-19 under 510(k) number K192460. The device is classified under product code PUM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sentinel Cerebral Protection System?

Sentinel Cerebral Protection System is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is Boston Scientific Corporation. The 510(k) number is K192460.

When did Sentinel Cerebral Protection System receive FDA 510(k) clearance?

Sentinel Cerebral Protection System received FDA 510(k) clearance on 2020-02-19, under 510(k) number K192460.

Who is the listed applicant for Sentinel Cerebral Protection System?

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 Sentinel Cerebral Protection System?

The FDA product code for Sentinel Cerebral Protection System is PUM.

其他以 Boston Scientific Corporation 為申請人之記錄

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相關器械（代碼：PUM）

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。

K261715栓塞器栓塞保護系統（EPC-03）Emboline, Inc.

官方來源

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