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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 the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical. It received FDA 510(k) clearance on 2016-11-22 under 510(k) 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. The listed applicant is Inari Medical. The 510(k) number is K162970.

When did FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator receive FDA 510(k) clearance?

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

Who is the listed applicant for FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator?

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, 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 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.

K260599INDIGO® 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 CorporationK252956Helo Thrombectomy SystemEndovascular Engineering, 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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