FDA 510(k)

MIVI Q 遠端進入導管

K 號：K212402 · 2021-12-16

決定日期2021-12-16

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

MIVI 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 2021-12-16 under 510(k) number K212402. 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 MIVI Q Distal Access Catheter?

MIVI Q Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Mivi Neuroscience, Inc.. The 510(k) number is K212402.

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

MIVI Q Distal Access Catheter received FDA 510(k) clearance on 2021-12-16, under 510(k) number K212402.

Who is the listed applicant for MIVI 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 MIVI Q Distal Access Catheter?

The FDA product code for MIVI 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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