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FDA 510(k)

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator

K-Number: K162970 · 2016-11-22

ApplicantInari Medical
Decision Date2016-11-22
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2016-11-22 under approval number K162970. 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, Aspiration Guide Catheter, Retraction Aspirator?

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Inari Medical. The 510(k) number is K162970.

When was FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator approved by the FDA?

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator received FDA 510(k) clearance on 2016-11-22, under approval number K162970.

What company makes FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator?

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator is manufactured by Inari Medical.

What is the FDA product code for FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator?

The FDA product code for FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator is QEW.

Related Clinical Trials

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Other Devices by Inari Medical

K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath K183198FlowTriever Retrieval/Aspiration System K182233FlowTriever Retrieval/Aspiration System K182531ClotTriever Thrombectomy System K181694FlowTriever Retrieval/Aspiration System K173672FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter

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Related Devices (Code: QEW)

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. K182167The ICHOR Panacea Vascular Embolectomy Catheter SystemIchor Vascular, 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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