FDA 510(k)

EVAC-MRI

K号: K252514 · 2025-11-05

决定日期2025-11-05

产品代码JXG

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定Unknown

器械摘要

EVAC-MRI is the device name listed in this FDA 510(k) record. The listed applicant is Phasor Health, LLC. It received FDA 510(k) clearance on 2025-11-05 under 510(k) number K252514. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Unknown.

常见问题

What is the EVAC-MRI?

EVAC-MRI is a medical device that received FDA 510(k) clearance on 2025-11-05. The listed applicant is Phasor Health, LLC. The 510(k) number is K252514.

When did EVAC-MRI receive FDA 510(k) clearance?

EVAC-MRI received FDA 510(k) clearance on 2025-11-05, under 510(k) number K252514.

Who is the listed applicant for EVAC-MRI?

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

What is the FDA product code for EVAC-MRI?

The FDA product code for EVAC-MRI is JXG.

列明Phasor Health, LLC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。

K252696LEGACY K252060GREEN K250505EZ-FIDUCIALS K243205EVAC

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 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 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

在 FDA 数据库中查看 →

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。