FDA 510(k)

反應71 管子

K 號：K241177 · 2024-05-28

申請人Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

決定日期2024-05-28

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

React 71 Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K241177. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the React 71 Catheter?

React 71 Catheter is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. The 510(k) number is K241177.

When did React 71 Catheter receive FDA 510(k) clearance?

React 71 Catheter received FDA 510(k) clearance on 2024-05-28, under 510(k) number K241177.

Who is the listed applicant for React 71 Catheter?

The FDA 510(k) record lists Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for React 71 Catheter?

The FDA product code for React 71 Catheter is DQY.

其他以 Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular 為申請人之記錄

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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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