FDA 510(k)

MEDRAD 馬克7 頸動脈注射系統

K 號：K193028 · 2019-12-05

決定日期2019-12-05

產品代碼DXT

諮詢委員會履歷

決定相當於

器材摘要

MEDRAD Mark 7 Arterion Injection System is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K193028. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MEDRAD Mark 7 Arterion Injection System?

MEDRAD Mark 7 Arterion Injection System is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K193028.

When did MEDRAD Mark 7 Arterion Injection System receive FDA 510(k) clearance?

MEDRAD Mark 7 Arterion Injection System received FDA 510(k) clearance on 2019-12-05, under 510(k) number K193028.

Who is the listed applicant for MEDRAD Mark 7 Arterion Injection System?

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

What is the FDA product code for MEDRAD Mark 7 Arterion Injection System?

The FDA product code for MEDRAD Mark 7 Arterion Injection System is DXT.

其他以 Bayer Medical Care, Inc. 為申請人之記錄

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K253688MEDRAD® 影像大量包裝轉移針 K252891MEDRAD MRXperion MR注射系統及MR注射系統針筒組；MEDRAD ISI2 模組（ISI2）K250893球節導向陣列（66295）K200280醫療設備規範文本翻譯： MEDRAD影像大量包裝轉移針 K192370MEDRAD Stellant FLEX CT 注射系統搭配 Certegra 工作站 K182273MEDRAD Stellant FLEX CT 注射系統搭配 Certegra 工作站，MEDRAD Stellant FLEX 静脈注射套件，MEDRAD Stellant CT 注射系統搭配 Certegra 工作站，MEDRAD Stellant 静脈注射套件，MEDRAD Stellant 接頭管路，P3T 心臟，P3T 肺動脈，P3T 腹部，ISI，Connect.CT

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相關器械（代碼：DXT）

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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