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FDA 510(k)

FlowTriever Retrieval/Aspiration System

K-Number: K191368 · 2019-06-17

ApplicantInari Medical
Decision Date2019-06-17
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. It received FDA 510(k) clearance on 2019-06-17 under 510(k) number K191368. 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 2019-06-17. The listed applicant is Inari Medical. The 510(k) number is K191368.

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

FlowTriever Retrieval/Aspiration System received FDA 510(k) clearance on 2019-06-17, under 510(k) number K191368.

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

The FDA 510(k) record lists Inari Medical 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.

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Other records listing Inari Medical 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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