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FDA 510(k)

Artix Thrombectomy Device

K-Number: K220600 · 2022-03-25

ApplicantInari Medical
Decision Date2022-03-25
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Artix Thrombectomy Device is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2022-03-25 under approval number K220600. 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 Artix Thrombectomy Device?

Artix Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Inari Medical. The 510(k) number is K220600.

When was Artix Thrombectomy Device approved by the FDA?

Artix Thrombectomy Device received FDA 510(k) clearance on 2022-03-25, under approval number K220600.

What company makes Artix Thrombectomy Device?

Artix Thrombectomy Device is manufactured by Inari Medical.

What is the FDA product code for Artix Thrombectomy Device?

The FDA product code for Artix Thrombectomy Device is QEW.

Related Clinical Trials

NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT07566598 Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution RECRUITING NCT07135895 The ArtixASCEND Study RECRUITING NCT06600542 Inari VISION Registry RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking 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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