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FDA 510(k)

FlowSaver Blood Return System (80-101)

K-Number: K231782 · 2023-07-14

ApplicantInari Medical, Inc.
Decision Date2023-07-14
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FlowSaver Blood Return System (80-101) is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-07-14 under approval number K231782. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Inari Medical, Inc.. The 510(k) number is K231782.

When was FlowSaver Blood Return System (80-101) approved by the FDA?

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

What company makes FlowSaver Blood Return System (80-101)?

FlowSaver Blood Return System (80-101) is manufactured by Inari Medical, Inc..

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.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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