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FDA 510(k)

FlowSaver Blood Return System

K-Number: K221483 · 2023-02-17

ApplicantInari Medical, Inc.
Decision Date2023-02-17
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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?

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05701917DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein ThrombosisRECRUITINGNCT06055920The PEERLESS II StudyACTIVE_NOT_RECRUITINGNCT06394739RevCore for In Stent ThrombosisRECRUITINGNCT06495996The Protrieve PROTECTOR StudyCOMPLETEDNCT06588634The PERSEVERE StudyRECRUITINGNCT06600542Inari VISION RegistryRECRUITING

Other records listing Inari Medical, Inc. as applicant

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Related Devices (Code: CAC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics CorporationK201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainAtrium Medical Corporation

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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