FDA 510(k)

遠端進入導管

K 號：K222948 · 2023-09-19

決定日期2023-09-19

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Q Distal Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mivi Neuroscience, Inc.. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K222948. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Q Distal Access Catheter?

Q Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is Mivi Neuroscience, Inc.. The 510(k) number is K222948.

When did Q Distal Access Catheter receive FDA 510(k) clearance?

Q Distal Access Catheter received FDA 510(k) clearance on 2023-09-19, under 510(k) number K222948.

Who is the listed applicant for Q Distal Access Catheter?

The FDA 510(k) record lists Mivi Neuroscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Distal Access Catheter?

The FDA product code for Q Distal Access Catheter is QJP.

其他以 Mivi Neuroscience, Inc. 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。

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相關器械（代碼：QJP）

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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