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FDA 510(k)

Carefusion NeutraClear 多功能扩展套件，带无针连接器

K号: K171118 · 2017-08-15

申请人Cair Lgl
决定日期2017-08-15
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

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K171118. 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 Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)?

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is Cair Lgl. The 510(k) number is K171118.

When did Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) receive FDA 510(k) clearance?

Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) received FDA 510(k) clearance on 2017-08-15, under 510(k) number K171118.

Who is the listed applicant for Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)?

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

What is the FDA product code for Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)?

The FDA product code for Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) 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Cair Lgl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。

K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorK231300Nutricair Enteral Syringe with ENFitK213258鼻胃管 - ENFit 端口 - 聚氯乙烯K210598儿童鼻胃管 - 单个ENFit端口K171117Carefusion NeutraClear 无针连接器 (EL-NC1000)K171132Carefusion NeutraClear 无针连接器

查看所有 7 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

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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