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FDA 510(k)

Clave™ 中性位移无针连接器

K号: K250616 · 2025-06-05

申请人Icu Medical, Inc.
决定日期2025-06-05
产品代码FPA
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Clave™ Neutral-Displacement Needlefree Connectors is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K250616. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Clave™ Neutral-Displacement Needlefree Connectors?

Clave™ Neutral-Displacement Needlefree Connectors is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Icu Medical, Inc.. The 510(k) number is K250616.

When did Clave™ Neutral-Displacement Needlefree Connectors receive FDA 510(k) clearance?

Clave™ Neutral-Displacement Needlefree Connectors received FDA 510(k) clearance on 2025-06-05, under 510(k) number K250616.

Who is the listed applicant for Clave™ Neutral-Displacement Needlefree Connectors?

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

What is the FDA product code for Clave™ Neutral-Displacement Needlefree Connectors?

The FDA product code for Clave™ Neutral-Displacement Needlefree Connectors is FPA.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Icu Medical, 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。

K252130LifeShield 输液安全软件套件K252006OTTO® 消毒帽K251980ClaveQS™ 包K242115Plum Duo® 精密静脉输液泵K242114Plum Solo® 精密静脉输液泵K242117LifeShield 输液安全软件套件

查看所有 14 个设备 →

相关器械（代码：FPA）

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。

K254123Ecomed 一次性给药套装Ecomed Solutions, LLCK261530iiSure 静脉输液器Deka Research and DevelopmentK252543AMSafe 注射器套装（BA-70075，BA-70071-D，BA-70070，BA-70071-P，BA-70072，BA-70072-F，BA-70071-DF，BA-70071-DF-120，FE01，FE04）Amsino International, Inc.K251375PuraCath Firefly 无针连接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定装置 [6426733]; nSet+ 稳定装置带 nSyte 无针连接器 (NFC) [6426731]; nSyte 无针连接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵输液套装Carefusion (Bd)

官方来源

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