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FDA 510(k)

VenaCore Thrombectomy Catheter (46-101)

K-Number: K234034 · 2024-02-09

ApplicantInari Medical, Inc.
Decision Date2024-02-09
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VenaCore Thrombectomy Catheter (46-101) is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2024-02-09 under approval number K234034. 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 VenaCore Thrombectomy Catheter (46-101)?

VenaCore Thrombectomy Catheter (46-101) is a medical device that received FDA 510(k) clearance on 2024-02-09. It is manufactured by Inari Medical, Inc.. The 510(k) number is K234034.

When was VenaCore Thrombectomy Catheter (46-101) approved by the FDA?

VenaCore Thrombectomy Catheter (46-101) received FDA 510(k) clearance on 2024-02-09, under approval number K234034.

What company makes VenaCore Thrombectomy Catheter (46-101)?

VenaCore Thrombectomy Catheter (46-101) is manufactured by Inari Medical, Inc..

What is the FDA product code for VenaCore Thrombectomy Catheter (46-101)?

The FDA product code for VenaCore Thrombectomy Catheter (46-101) is QEW.

Related Clinical Trials

NCT06394739 RevCore for In Stent Thrombosis RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING

Other Devices by Inari Medical, Inc.

K163549ClotTriever Thrombectomy System K181325FlowTriever Retrieval/Aspiration System K180466FlowTriever Retrieval/Aspiration System K180329ClotTriever Thrombectomy System K203333Triever20 Curve Catheter K212632ClotTriever Thrombectomy System

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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.

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