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FDA 510(k)

VITRUVIAN 渗透泵

K号: K170629 · 2017-06-22

决定日期2017-06-22
产品代码QPB
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

VITRUVIAN INFILTRATION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Black & Black Surgical, Inc.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K170629. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITRUVIAN INFILTRATION PUMP?

VITRUVIAN INFILTRATION PUMP is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Black & Black Surgical, Inc.. The 510(k) number is K170629.

When did VITRUVIAN INFILTRATION PUMP receive FDA 510(k) clearance?

VITRUVIAN INFILTRATION PUMP received FDA 510(k) clearance on 2017-06-22, under 510(k) number K170629.

Who is the listed applicant for VITRUVIAN INFILTRATION PUMP?

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

What is the FDA product code for VITRUVIAN INFILTRATION PUMP?

The FDA product code for VITRUVIAN INFILTRATION PUMP is QPB.

相关临床试验

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。

列明Black & Black Surgical, 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。

相关器械(代码:QPB)

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。

官方来源

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