FDA 510(k)

外部脑脊液引流室导管，外部脑脊液引流腰椎导管

K号: K242974 · 2025-06-20

决定日期2025-06-20

产品代码JXG

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决定实质等同

器械摘要

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K242974. 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 External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Sophysa. The 510(k) number is K242974.

When did External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters receive FDA 510(k) clearance?

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters received FDA 510(k) clearance on 2025-06-20, under 510(k) number K242974.

Who is the listed applicant for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

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

What is the FDA product code for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

The FDA product code for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is JXG.

列明Sophysa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。

K252241Pressio 3多参数神经监测系统 K250636Sophy Mini 单压力阀 (SM1)K222422Polaris 阀电子读数仪

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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