FDA 510(k)

PowerFlow 血液透析 I.V. 端口

K号: K163001 · 2017-04-17

决定日期2017-04-17

产品代码PTD

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

PowerFlow Apheresis I.V. Port is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-04-17 under 510(k) number K163001. The device is classified under product code PTD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PowerFlow Apheresis I.V. Port?

PowerFlow Apheresis I.V. Port is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K163001.

When did PowerFlow Apheresis I.V. Port receive FDA 510(k) clearance?

PowerFlow Apheresis I.V. Port received FDA 510(k) clearance on 2017-04-17, under 510(k) number K163001.

Who is the listed applicant for PowerFlow Apheresis I.V. Port?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerFlow Apheresis I.V. Port?

The FDA product code for PowerFlow Apheresis I.V. Port is PTD.

列明C.R. Bard, 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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