FDA 510(k)

GALAXY G3 Mini 微线圈输送系统

K号: K171862 · 2017-09-25

决定日期2017-09-25

产品代码HCG

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决定实质等同

器械摘要

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.

常见问题

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.

列明Codman & Shurtleff, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193380CERENOVUS大口径导管；CERENOVUS吸引管套装 K191237CERENOVUS大口径导管 K173192CereLink ICP 传感器基本套件，CereLink ICP 传感器金属颅骨螺栓套件，CereLink ICP 传感器塑料颅骨螺栓套件，CereLink ICP 传感器心室导管套件 K172537Codman EDS 3 CSF外部引流系统，Codman EDS 3 CSF外部引流系统收集袋 K172022CODMAN脑积水阀门、导管及配件（捆绑）K171747MICRUSFRAME 10 抗拉伸微线圈输送系统，MICRUSFRAME 18 抗拉伸微线圈输送系统，DELTAFILL 18 抗拉伸微线圈输送系统，DELTAXSFT 10 抗拉伸微线圈输送系统，GALAXY G3 FILL 和 GALAXY G3 XSFT 抗拉伸微线圈输送系统

查看所有 11 个设备 →

相关器械（代码：HCG）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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