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FDA 510(k)

Q3 遠端進入導管，Q4 遠端進入導管，Q5 遠端進入導管，Q6 遠端進入導管

K 號：K192558 · 2020-04-06

申請人Mivi Neurovascular
決定日期2020-04-06
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mivi Neurovascular. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K192558. 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 Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter?

Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Mivi Neurovascular. The 510(k) number is K192558.

When did Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter receive FDA 510(k) clearance?

Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter received FDA 510(k) clearance on 2020-04-06, under 510(k) number K192558.

Who is the listed applicant for Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter?

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

What is the FDA product code for Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter?

The FDA product code for Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter is DQY.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：DQY）

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

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