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FDA 510(k)

CADD Yellow High Volume Administration Set with NRFit connector

K号: K172592 · 2018-05-17

申请人Smiths Medical Asd, Inc.
决定日期2018-05-17
产品代码PWH
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

CADD Yellow High Volume Administration Set with NRFit connector is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K172592. The device is classified under product code PWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CADD Yellow High Volume Administration Set with NRFit connector?

CADD Yellow High Volume Administration Set with NRFit connector is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172592.

When did CADD Yellow High Volume Administration Set with NRFit connector receive FDA 510(k) clearance?

CADD Yellow High Volume Administration Set with NRFit connector received FDA 510(k) clearance on 2018-05-17, under 510(k) number K172592.

Who is the listed applicant for CADD Yellow High Volume Administration Set with NRFit connector?

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

What is the FDA product code for CADD Yellow High Volume Administration Set with NRFit connector?

The FDA product code for CADD Yellow High Volume Administration Set with NRFit connector is PWH.

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。

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列明Smiths Medical Asd, 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。

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查看所有 16 个设备 →

相关器械（代码：PWH）

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。

K221319BD Alaris® 泵硬膜外输液套装Care FusionK211649PCEA 注射器套装Baxter Healthcare CorporationK162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc.

官方来源

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