FDA 510(k)

Provena™ 中线导管

K号: K213203 · 2022-05-13

决定日期2022-05-13

产品代码PND

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

Provena(TM) Midline Catheter 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 2022-05-13 under 510(k) number K213203. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Provena(TM) Midline Catheter?

Provena(TM) Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K213203.

When did Provena(TM) Midline Catheter receive FDA 510(k) clearance?

Provena(TM) Midline Catheter received FDA 510(k) clearance on 2022-05-13, under 510(k) number K213203.

Who is the listed applicant for Provena(TM) Midline Catheter?

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 Provena(TM) Midline Catheter?

The FDA product code for Provena(TM) Midline Catheter is PND.

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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