FDA 510(k)

FlowSaver 血液回输系统 (80-101)

K号: K231782 · 2023-07-14

决定日期2023-07-14

产品代码CAC

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决定实质等同

器械摘要

FlowSaver Blood Return System (80-101) 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 2023-07-14 under 510(k) number K231782. 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 (80-101)?

FlowSaver Blood Return System (80-101) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Inari Medical, Inc.. The 510(k) number is K231782.

When did FlowSaver Blood Return System (80-101) receive FDA 510(k) clearance?

FlowSaver Blood Return System (80-101) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K231782.

Who is the listed applicant for FlowSaver Blood Return System (80-101)?

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 (80-101)?

The FDA product code for FlowSaver Blood Return System (80-101) 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。

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官方来源

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