KIDNEYvault便携式肾脏灌注系统
K号: K234060 · 2024-10-23
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决定日期2024-10-23
产品代码KDN
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
KIDNEYvault Portable Renal Perfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Paragonix Technologies. It received FDA 510(k) clearance on 2024-10-23 under 510(k) number K234060. 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 KIDNEYvault Portable Renal Perfusion System?
KIDNEYvault Portable Renal Perfusion System is a medical device that received FDA 510(k) clearance on 2024-10-23. The listed applicant is Paragonix Technologies. The 510(k) number is K234060.
When did KIDNEYvault Portable Renal Perfusion System receive FDA 510(k) clearance?
KIDNEYvault Portable Renal Perfusion System received FDA 510(k) clearance on 2024-10-23, under 510(k) number K234060.
Who is the listed applicant for KIDNEYvault Portable Renal Perfusion System?
The FDA 510(k) record lists Paragonix Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KIDNEYvault Portable Renal Perfusion System?
The FDA product code for KIDNEYvault Portable Renal Perfusion System is KDN.
相关临床试验
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。
列明Paragonix Technologies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。
相关器械（代码：KDN）
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。
K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ 肝脏保护系统Traferox Technologies, Inc.K254305BAROguard 肺脏捐赠者保存系统Paragonix Technologies, Inc.K243618EasiSlush® 生理盐水溶液，用于无菌冰冻混合物制备 (BTLE-1250)Bridge TO LifeK243870X°Port 肺脏保护系统；X°Port 肺脏保护解决方案Traferox Technologies, Inc.K243998DCX 一次性盒式（DCX）Institut Geroges Lopez
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。
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