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FDA 510(k)

ReVene Thrombectomy Catheter

K-Number: K201705 · 2020-12-22

ApplicantVetex Medical, Ltd.
Decision Date2020-12-22
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ReVene Thrombectomy Catheter is a medical device manufactured by Vetex Medical, Ltd.. It received FDA 510(k) clearance on 2020-12-22 under approval number K201705. 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 ReVene Thrombectomy Catheter?

ReVene Thrombectomy Catheter is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Vetex Medical, Ltd.. The 510(k) number is K201705.

When was ReVene Thrombectomy Catheter approved by the FDA?

ReVene Thrombectomy Catheter received FDA 510(k) clearance on 2020-12-22, under approval number K201705.

What company makes ReVene Thrombectomy Catheter?

ReVene Thrombectomy Catheter is manufactured by Vetex Medical, Ltd..

What is the FDA product code for ReVene Thrombectomy Catheter?

The FDA product code for ReVene Thrombectomy Catheter 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

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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