FDA 510(k)

Sangria Thrombectomy System

K-Number: K251207 · 2026-01-07

Decision Date2026-01-07

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sangria Thrombectomy System is a medical device manufactured by Avantec Vascular Corporation. It received FDA 510(k) clearance on 2026-01-07 under approval number K251207. 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 Sangria Thrombectomy System?

Sangria Thrombectomy System is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by Avantec Vascular Corporation. The 510(k) number is K251207.

When was Sangria Thrombectomy System approved by the FDA?

Sangria Thrombectomy System received FDA 510(k) clearance on 2026-01-07, under approval number K251207.

What company makes Sangria Thrombectomy System?

Sangria Thrombectomy System is manufactured by Avantec Vascular Corporation.

What is the FDA product code for Sangria Thrombectomy System?

The FDA product code for Sangria Thrombectomy System 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 Avantec Vascular Corporation

K170987Captus Vascular Retrieval System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.