FDA 510(k)

无针连接器

K号: K210217 · 2021-05-17

决定日期2021-05-17

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

Needleless Connector is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2021-05-17 under 510(k) number K210217. 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 Needleless Connector?

Needleless Connector is a medical device that received FDA 510(k) clearance on 2021-05-17. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K210217.

When did Needleless Connector receive FDA 510(k) clearance?

Needleless Connector received FDA 510(k) clearance on 2021-05-17, under 510(k) number K210217.

Who is the listed applicant for Needleless Connector?

The FDA 510(k) record lists Jiangsu Caina Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Needleless Connector?

The FDA product code for Needleless Connector is FPA.

列明Jiangsu Caina Medical Co.,Ltd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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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。

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官方来源

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