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FDA 510(k)

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter

K-Number: K173672 · 2018-02-05

ApplicantInari Medical
Decision Date2018-02-05
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2018-02-05 under approval number K173672. 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?

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter is a medical device that received FDA 510(k) clearance on 2018-02-05. It is manufactured by Inari Medical. The 510(k) number is K173672.

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

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter received FDA 510(k) clearance on 2018-02-05, under approval number K173672.

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

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

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

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

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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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