FDA 510(k)

X°Port 肺脏保护系统；X°Port 肺脏保护解决方案

K号: K243870 · 2025-05-01

决定日期2025-05-01

产品代码KDN

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决定实质等同

器械摘要

X°Port Lung Preservation System; X°Port Lung Preservation Solution is the device name listed in this FDA 510(k) record. The listed applicant is Traferox Technologies, Inc.. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K243870. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X°Port Lung Preservation System; X°Port Lung Preservation Solution?

X°Port Lung Preservation System; X°Port Lung Preservation Solution is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Traferox Technologies, Inc.. The 510(k) number is K243870.

When did X°Port Lung Preservation System; X°Port Lung Preservation Solution receive FDA 510(k) clearance?

X°Port Lung Preservation System; X°Port Lung Preservation Solution received FDA 510(k) clearance on 2025-05-01, under 510(k) number K243870.

Who is the listed applicant for X°Port Lung Preservation System; X°Port Lung Preservation Solution?

FDA 510(k)记录中列出Traferox Technologies, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for X°Port Lung Preservation System; X°Port Lung Preservation Solution?

The FDA product code for X°Port Lung Preservation System; X°Port Lung Preservation Solution is KDN.

列明Traferox Technologies, 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。

K261913X°Port 心脏保护系统 K260456VI°Port™ 肝脏保护系统 K240650LungProtect

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。