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FDA 510(k)

FlowTriever Retrieval/Aspiration System

K-Number: K201541 · 2020-12-04

ApplicantInari Medical
Decision Date2020-12-04
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlowTriever Retrieval/Aspiration System is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2020-12-04 under approval number K201541. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlowTriever Retrieval/Aspiration System?

FlowTriever Retrieval/Aspiration System is a medical device that received FDA 510(k) clearance on 2020-12-04. It is manufactured by Inari Medical. The 510(k) number is K201541.

When was FlowTriever Retrieval/Aspiration System approved by the FDA?

FlowTriever Retrieval/Aspiration System received FDA 510(k) clearance on 2020-12-04, under approval number K201541.

What company makes FlowTriever Retrieval/Aspiration System?

FlowTriever Retrieval/Aspiration System is manufactured by Inari Medical.

What is the FDA product code for FlowTriever Retrieval/Aspiration System?

The FDA product code for FlowTriever Retrieval/Aspiration System is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING

Other Devices by Inari Medical

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath K183198FlowTriever Retrieval/Aspiration System K182233FlowTriever Retrieval/Aspiration System K182531ClotTriever Thrombectomy System K181694FlowTriever Retrieval/Aspiration System

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Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc.

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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