FDA 510(k)

Protek Duo 静脉扩张器套装，Protek Solo 静脉扩张器套装

K号: K162181 · 2017-01-06

决定日期2017-01-06

产品代码DRE

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K162181. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K162181.

When did Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set receive FDA 510(k) clearance?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set received FDA 510(k) clearance on 2017-01-06, under 510(k) number K162181.

Who is the listed applicant for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

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

What is the FDA product code for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

The FDA product code for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is DRE.

列明Cardiacassist, 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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