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 a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2025-03-13 under approval 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. It is manufactured by Inari Medical, Inc.. The 510(k) number is K250088.
When was FlowTriever2 Catheter approved by the FDA?
FlowTriever2 Catheter received FDA 510(k) clearance on 2025-03-13, under approval number K250088.
What company makes FlowTriever2 Catheter?
FlowTriever2 Catheter is manufactured by Inari Medical, Inc..
What is the FDA product code for FlowTriever2 Catheter?
The FDA product code for FlowTriever2 Catheter is QEW.
Other Devices by Inari Medical, Inc.
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.