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FDA 510(k)

Carefusion NeutraClear 无针连接器 (EL-NC1000)

K号: K171117 · 2017-09-01

申请人Cair Lgl
决定日期2017-09-01
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 Needle-free connector (EL-NC1000) is the device name listed in this FDA 510(k) record. The listed applicant is Cair Lgl. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K171117. 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 Needle-free connector (EL-NC1000)?

Carefusion NeutraClear Needle-free connector (EL-NC1000) is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Cair Lgl. The 510(k) number is K171117.

When did Carefusion NeutraClear Needle-free connector (EL-NC1000) receive FDA 510(k) clearance?

Carefusion NeutraClear Needle-free connector (EL-NC1000) received FDA 510(k) clearance on 2017-09-01, under 510(k) number K171117.

Who is the listed applicant for Carefusion NeutraClear Needle-free connector (EL-NC1000)?

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 Needle-free connector (EL-NC1000)?

The FDA product code for Carefusion NeutraClear Needle-free connector (EL-NC1000) 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K171118Carefusion NeutraClear 多功能扩展套件，带无针连接器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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