FDA 510(k)

GALAXY G3 Mini 微线圈輸送系統

K 號：K171862 · 2017-09-25

決定日期2017-09-25

產品代碼HCG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

GALAXY G3 Mini Microcoil Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K171862. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GALAXY G3 Mini Microcoil Delivery System?

GALAXY G3 Mini Microcoil Delivery System is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K171862.

When did GALAXY G3 Mini Microcoil Delivery System receive FDA 510(k) clearance?

GALAXY G3 Mini Microcoil Delivery System received FDA 510(k) clearance on 2017-09-25, under 510(k) number K171862.

Who is the listed applicant for GALAXY G3 Mini Microcoil Delivery System?

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

What is the FDA product code for GALAXY G3 Mini Microcoil Delivery System?

The FDA product code for GALAXY G3 Mini Microcoil Delivery System is HCG.

其他以 Codman & Shurtleff, Inc. 為申請人之記錄

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相關器械（代碼：HCG）

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