FDA 510(k)

微針™先進微接入系統

K 號：K232609 · 2023-09-27

決定日期2023-09-27

產品代碼DRE

諮詢委員會履歷

決定相當於

器材摘要

Micro Ace™ Advanced Micro Access System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K232609. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Micro Ace™ Advanced Micro Access System?

Micro Ace™ Advanced Micro Access System is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K232609.

When did Micro Ace™ Advanced Micro Access System receive FDA 510(k) clearance?

Micro Ace™ Advanced Micro Access System received FDA 510(k) clearance on 2023-09-27, under 510(k) number K232609.

Who is the listed applicant for Micro Ace™ Advanced Micro Access System?

FDA 510(k) 記錄將 Merit Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Micro Ace™ Advanced Micro Access System?

The FDA product code for Micro Ace™ Advanced Micro Access System is DRE.

其他以 Merit Medical Systems, 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：DRE）

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。

K261310FlexTract 可調向旋轉擴張針鞘組Merit Medical Systems, Inc.K253616ProtekDilate 血管通路套件Sorin Group Italia S.R.L.K251325VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.K242229微針金進階微針接入系統Merit Medical Systems, Inc.K241720VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.K233647VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.

官方來源

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