FDA 510(k)

BIB支架置入導管

K 號：K161451 · 2016-09-22

決定日期2016-09-22

產品代碼NVM

諮詢委員會履歷

決定相當於

器材摘要

BIB Stent Placement Catheter is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K161451. The device is classified under product code NVM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIB Stent Placement Catheter?

BIB Stent Placement Catheter is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is NuMED, Inc.. The 510(k) number is K161451.

When did BIB Stent Placement Catheter receive FDA 510(k) clearance?

BIB Stent Placement Catheter received FDA 510(k) clearance on 2016-09-22, under 510(k) number K161451.

Who is the listed applicant for BIB Stent Placement Catheter?

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

What is the FDA product code for BIB Stent Placement Catheter?

The FDA product code for BIB Stent Placement Catheter is NVM.

其他以 NuMED, 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。

K213915BIB支架置入導管 K211910Z-6 心房中隔穿刺針 K211134BIB支架置入導管 K190974D'Vill 引入器 K171206D'Vill 引入器 K160598REBOA 气球導管

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相關器械（代碼：NVM）

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。

K213915BIB支架置入導管NuMED, Inc.K211134BIB支架置入導管NuMED, Inc.K160889BIB支架置入導管NuMED, Inc.

官方來源

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