FDA 510(k)

Codman Certas Plus电子工具包

K号: K181902 · 2018-10-25

决定日期2018-10-25

产品代码JXG

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决定实质等同

器械摘要

Codman Certas Plus Electronic Tool Kit is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K181902. 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 Certas Plus Electronic Tool Kit?

Codman Certas Plus Electronic Tool Kit is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K181902.

When did Codman Certas Plus Electronic Tool Kit receive FDA 510(k) clearance?

Codman Certas Plus Electronic Tool Kit received FDA 510(k) clearance on 2018-10-25, under 510(k) number K181902.

Who is the listed applicant for Codman Certas Plus Electronic Tool Kit?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Codman Certas Plus Electronic Tool Kit?

The FDA product code for Codman Certas Plus Electronic Tool Kit is JXG.

列明Integra Lifesciences Corp.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。

K183581Codman一次性穿孔器 K183406CereLink ICP 监测仪，CereLink ICP 延长线 K182265CodMan Certas Plus可编程阀门

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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