FDA 510(k)

CODMAN脑积水阀门、导管及配件（捆绑）

K号: K172022 · 2017-10-03

决定日期2017-10-03

产品代码JXG

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决定实质等同

器械摘要

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) 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 2017-10-03 under 510(k) number K172022. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is a medical device that received FDA 510(k) clearance on 2017-10-03. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K172022.

When did CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) receive FDA 510(k) clearance?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) received FDA 510(k) clearance on 2017-10-03, under 510(k) number K172022.

Who is the listed applicant for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

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 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

The FDA product code for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is JXG.

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 K171862GALAXY G3 Mini 微线圈输送系统 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：JXG）

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。

K261004Codman®远端腹膜导管，钡开放端（82-1682）；Codman®HOLTER®腹膜导管（SALMON设计）（82-1684）Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini 单压力阀 (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís分流导管，带Bactiseal和Endexo技术Integra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821761）；Codman Libertís™ 1.9 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821762）Integra Lifesciences Production Corporation

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。