FDA 510(k)

標誌性REBOA導管

K 號：K214060 · 2022-09-19

決定日期2022-09-19

產品代碼MJN

諮詢委員會履歷

決定相當於

器材摘要

LANDMARK REBOA Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Zien Medical Technologies, Inc.. It received FDA 510(k) clearance on 2022-09-19 under 510(k) number K214060. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LANDMARK REBOA Catheter?

LANDMARK REBOA Catheter is a medical device that received FDA 510(k) clearance on 2022-09-19. The listed applicant is Zien Medical Technologies, Inc.. The 510(k) number is K214060.

When did LANDMARK REBOA Catheter receive FDA 510(k) clearance?

LANDMARK REBOA Catheter received FDA 510(k) clearance on 2022-09-19, under 510(k) number K214060.

Who is the listed applicant for LANDMARK REBOA Catheter?

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

What is the FDA product code for LANDMARK REBOA Catheter?

The FDA product code for LANDMARK REBOA Catheter is MJN.

其他以 Zien Medical Technologies, Inc. 為申請人之記錄

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K240915ZIEN IO 骨內進入系統

相關器械（代碼：MJN）

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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