FDA 510(k)

FlowSaver 血液回输系统

K号: K221483 · 2023-02-17

决定日期2023-02-17

产品代码CAC

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决定实质等同

器械摘要

FlowSaver Blood Return System is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221483. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FlowSaver Blood Return System?

FlowSaver Blood Return System is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Inari Medical, Inc.. The 510(k) number is K221483.

When did FlowSaver Blood Return System receive FDA 510(k) clearance?

FlowSaver Blood Return System received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221483.

Who is the listed applicant for FlowSaver Blood Return System?

FDA 510(k)记录中列出Inari Medical, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for FlowSaver Blood Return System?

The FDA product code for FlowSaver Blood Return System is CAC.

列明Inari Medical, 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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相关器械（代码：CAC）

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。

K241236XTRA系列套装；XTRA隔离套装Sorin Group Italia S.R.L.K240426Aventus凝血管理系统Inquis Medical K240584XTRA 自动输血系统（含 XTRA 碗套装）Sorin Group Italia S.R.L.K231782FlowSaver 血液回输系统 (80-101)Inari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation K201305自动输血（ATS）胸腔引流管：海洋水封胸腔引流管，Oasis 干式吸引水封胸腔引流管，Express 干式密封胸腔引流管Atrium Medical Corporation

官方来源

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