FDA 510(k)

Codman Libertís分流导管，带Bactiseal和Endexo技术

K号: K243531 · 2025-08-08

申请人Integra Lifesciences Production Corporation

决定日期2025-08-08

产品代码JXG

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决定实质等同

器械摘要

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K243531. 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 Libertís Shunt Catheter with Bactiseal and Endexo Technology?

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K243531.

When did Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology receive FDA 510(k) clearance?

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology received FDA 510(k) clearance on 2025-08-08, under 510(k) number K243531.

Who is the listed applicant for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

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

What is the FDA product code for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

The FDA product code for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is JXG.

列明Integra Lifesciences Production Corporation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。

K261004Codman®远端腹膜导管，钡开放端（82-1682）；Codman®HOLTER®腹膜导管（SALMON设计）（82-1684）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）K232890CereLink ICP 监测仪（826820），CereLink ICP 延长线（826845）K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set K223330Certas Plus 可编程阀门

查看所有 9 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 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 K242974外部脑脊液引流室导管，外部脑脊液引流腰椎导管Sophysa

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。