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FDA 510(k)

SelectSite C304 可調向導管系統，C315 導管輸送系統

K 號：K223178 · 2022-11-08

申請人Medtronic
決定日期2022-11-08
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

SelectSite C304 Deflectable Catheter System, C315 Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2022-11-08 under 510(k) number K223178. 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 SelectSite C304 Deflectable Catheter System, C315 Delivery System?

SelectSite C304 Deflectable Catheter System, C315 Delivery System is a medical device that received FDA 510(k) clearance on 2022-11-08. The listed applicant is Medtronic. The 510(k) number is K223178.

When did SelectSite C304 Deflectable Catheter System, C315 Delivery System receive FDA 510(k) clearance?

SelectSite C304 Deflectable Catheter System, C315 Delivery System received FDA 510(k) clearance on 2022-11-08, under 510(k) number K223178.

Who is the listed applicant for SelectSite C304 Deflectable Catheter System, C315 Delivery System?

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

What is the FDA product code for SelectSite C304 Deflectable Catheter System, C315 Delivery System?

The FDA product code for SelectSite C304 Deflectable Catheter System, C315 Delivery System is DQY.

相關臨床試驗

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其他以 Medtronic 為申請人之記錄

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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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