FDA 510(k)

高爾成型與封閉氣球導管

K 號：K172567 · 2018-01-31

決定日期2018-01-31

產品代碼MJN

諮詢委員會履歷

決定相當於

器材摘要

GORE Molding and Occlusion Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K172567. 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 GORE Molding and Occlusion Balloon Catheter?

GORE Molding and Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is W. L. Gore and Associates, Inc.. The 510(k) number is K172567.

When did GORE Molding and Occlusion Balloon Catheter receive FDA 510(k) clearance?

GORE Molding and Occlusion Balloon Catheter received FDA 510(k) clearance on 2018-01-31, under 510(k) number K172567.

Who is the listed applicant for GORE Molding and Occlusion Balloon Catheter?

The FDA 510(k) record lists W. L. Gore and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE Molding and Occlusion Balloon Catheter?

The FDA product code for GORE Molding and Occlusion Balloon Catheter is MJN.

其他以 W. L. Gore and Associates, 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。

K250410GORE® 三葉球囊心导管 K240083GORE® PROPAATEN® 頸動脈移植物 K232312GORE® PROPAATEN® 頸動脈移植物 K233551GORE® ACUSEAL 頸動脈移植管 K231505GORE® ACUSEAL 頸動脈移植管 K222919GORE® ENFORM 生物材質

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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。

K243795pREBOA-PRO 管針Prytime Medical Devices, Inc.K251358橋接加壓氣球（590-002）Philips Image Guided Therapy Devices K221294preCARDIA 閉塞系統Abiomed, Inc.K214060標誌性REBOA導管Zien Medical Technologies, Inc.K211610福吉蒂塞鎖針管Edwards Lifesciences, LLC K212324RenovoCathRenovorx, Inc.

官方來源

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