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FDA 510(k)

FlowTriever Retrieval/Aspiration System

K-Number: K180466 · 2018-05-17

ApplicantInari Medical, Inc.
Decision Date2018-05-17
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlowTriever Retrieval/Aspiration 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 2018-05-17 under 510(k) number K180466. 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 2018-05-17. The listed applicant is Inari Medical, Inc.. The 510(k) number is K180466.

When did FlowTriever Retrieval/Aspiration System receive FDA 510(k) clearance?

FlowTriever Retrieval/Aspiration System received FDA 510(k) clearance on 2018-05-17, under 510(k) number K180466.

Who is the listed applicant for FlowTriever Retrieval/Aspiration 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 FlowTriever Retrieval/Aspiration System?

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

Related Clinical Trials

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Other records listing Inari Medical, Inc. as applicant

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Related Devices (Code: QEW)

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.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular 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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