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FDA 510(k)

FlowTriever2 Catheter

K-Number: K250088 · 2025-03-13

ApplicantInari Medical, Inc.
Decision Date2025-03-13
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlowTriever2 Catheter 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 2025-03-13 under 510(k) number K250088. 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 FlowTriever2 Catheter?

FlowTriever2 Catheter is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Inari Medical, Inc.. The 510(k) number is K250088.

When did FlowTriever2 Catheter receive FDA 510(k) clearance?

FlowTriever2 Catheter received FDA 510(k) clearance on 2025-03-13, under 510(k) number K250088.

Who is the listed applicant for FlowTriever2 Catheter?

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 FlowTriever2 Catheter?

The FDA product code for FlowTriever2 Catheter is QEW.

Related Clinical Trials

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Related Devices (Code: QEW)

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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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