FDA 510(k)

PleuraFlow系统ZIP附件

K号: K191733 · 2019-07-26

决定日期2019-07-26

产品代码OTK

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

The ZIP Accessory Shuttle for PleuraFlow System is the device name listed in this FDA 510(k) record. The listed applicant is Clearflow, Inc.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191733. The device is classified under product code OTK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the The ZIP Accessory Shuttle for PleuraFlow System?

The ZIP Accessory Shuttle for PleuraFlow System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Clearflow, Inc.. The 510(k) number is K191733.

When did The ZIP Accessory Shuttle for PleuraFlow System receive FDA 510(k) clearance?

The ZIP Accessory Shuttle for PleuraFlow System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191733.

Who is the listed applicant for The ZIP Accessory Shuttle for PleuraFlow System?

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

What is the FDA product code for The ZIP Accessory Shuttle for PleuraFlow System?

The FDA product code for The ZIP Accessory Shuttle for PleuraFlow System is OTK.

列明Clearflow, 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。

K203394PleuraFlow System with FlowGlide K182067PleuraFlow System with FlowGlide Extra Drainage Length K163139PleuraFlow System with FlowGlide K153681PleuraFlow 系统

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。