FDA 510(k)

BD Cathena 安全静脉留置针

K号: K201717 · 2020-09-22

申请人Becton Dickinson Infusion Therapy Systems, Inc.

决定日期2020-09-22

产品代码FOZ

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

BD Cathena Safety IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2020-09-22 under 510(k) number K201717. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BD Cathena Safety IV Catheter?

BD Cathena Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2020-09-22. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K201717.

When did BD Cathena Safety IV Catheter receive FDA 510(k) clearance?

BD Cathena Safety IV Catheter received FDA 510(k) clearance on 2020-09-22, under 510(k) number K201717.

Who is the listed applicant for BD Cathena Safety IV Catheter?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Cathena Safety IV Catheter?

The FDA product code for BD Cathena Safety IV Catheter is FOZ.

列明Becton Dickinson Infusion Therapy Systems, 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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官方来源

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