FDA 510(k)

Huber 针头输液器，安全Huber 针头输液器

K号: K200463 · 2021-04-07

决定日期2021-04-07

产品代码PTI

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

Huber Needle Infusion Set, Safety Huber Needle Infusion Set 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 2021-04-07 under 510(k) number K200463. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

Huber Needle Infusion Set, Safety Huber Needle Infusion Set is a medical device that received FDA 510(k) clearance on 2021-04-07. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K200463.

When did Huber Needle Infusion Set, Safety Huber Needle Infusion Set receive FDA 510(k) clearance?

Huber Needle Infusion Set, Safety Huber Needle Infusion Set received FDA 510(k) clearance on 2021-04-07, under 510(k) number K200463.

Who is the listed applicant for Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

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 Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

The FDA product code for Huber Needle Infusion Set, Safety Huber Needle Infusion Set is PTI.

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。

K232781安全滑动式血液采集套装 K233190ENFit 连接器 K230635笔式针头 K220184Pump Alignment Syringe K211593肠内泵注射器 K210217无针连接器

查看所有 15 个设备 →

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。