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FDA 510(k)

Aventus Thrombectomy System (IM-2100)

K-Number: K250668 · 2025-03-25

ApplicantInquis Medical
Decision Date2025-03-25
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aventus Thrombectomy System (IM-2100) is a medical device manufactured by Inquis Medical. It received FDA 510(k) clearance on 2025-03-25 under approval number K250668. 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 Aventus Thrombectomy System (IM-2100)?

Aventus Thrombectomy System (IM-2100) is a medical device that received FDA 510(k) clearance on 2025-03-25. It is manufactured by Inquis Medical. The 510(k) number is K250668.

When was Aventus Thrombectomy System (IM-2100) approved by the FDA?

Aventus Thrombectomy System (IM-2100) received FDA 510(k) clearance on 2025-03-25, under approval number K250668.

What company makes Aventus Thrombectomy System (IM-2100)?

Aventus Thrombectomy System (IM-2100) is manufactured by Inquis Medical.

What is the FDA product code for Aventus Thrombectomy System (IM-2100)?

The FDA product code for Aventus Thrombectomy System (IM-2100) is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING NCT07135895 The ArtixASCEND Study RECRUITING

Other Devices by Inquis Medical

K232730Aventus Thrombectomy System K240426Aventus Clot Management System K240117Aventus Thrombectomy System (IM-2001/IM-0002) K251189Aventus Thrombectomy System K250202Aventus Thrombectomy System K260091Aventus Introducer Sheath

View all 8 devices →

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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