FDA 510(k)

優質堡壘血管栓

K 號：K212817 · 2021-12-15

決定日期2021-12-15

產品代碼KRD

諮詢委員會履歷

決定相當於

器材摘要

Merit Siege Vascular Plug is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical System, Inc.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K212817. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Merit Siege Vascular Plug?

Merit Siege Vascular Plug is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Merit Medical System, Inc.. The 510(k) number is K212817.

When did Merit Siege Vascular Plug receive FDA 510(k) clearance?

Merit Siege Vascular Plug received FDA 510(k) clearance on 2021-12-15, under 510(k) number K212817.

Who is the listed applicant for Merit Siege Vascular Plug?

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

What is the FDA product code for Merit Siege Vascular Plug?

The FDA product code for Merit Siege Vascular Plug is KRD.

其他以 Merit Medical System, 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。

K252527表面內外進入導管系統 K231468SCOUT MD 外科導航系統 K230636麥斯特羅微導管 K193571Go2Wire 引導絲

相關器械（代碼：KRD）

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。

K252812UniPearls® 遮斷微膠球Suzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO 可調適性栓塊Boston Scientific Corporation K261866Concerto Versa™ 可拆式線圈Medtronic, Inc.K260635HARBOR 閉塞設備Nuvascular, Inc.K260508LOBO血管栓塞系統Okami Medical, Inc.K253511Concerto Versa™ 可拆式線圈Medtronic, Inc.

官方來源

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