FDA 510(k)

Codman EDS 3 CSF外部引流系统，Codman EDS 3 CSF外部引流系统收集袋

K号: K172537 · 2017-10-16

决定日期2017-10-16

产品代码JXG

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决定实质等同

器械摘要

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag 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 2017-10-16 under 510(k) number K172537. 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 EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag?

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag is a medical device that received FDA 510(k) clearance on 2017-10-16. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K172537.

When did Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag receive FDA 510(k) clearance?

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag received FDA 510(k) clearance on 2017-10-16, under 510(k) number K172537.

Who is the listed applicant for Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag?

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 EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag?

The FDA product code for Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag 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。

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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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