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FDA 510(k)

Akura Thrombectomy System

K-Number: K251070 · 2025-11-25

ApplicantAkura Medical
Decision Date2025-11-25
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Akura Thrombectomy System is a medical device manufactured by Akura Medical. It received FDA 510(k) clearance on 2025-11-25 under approval number K251070. 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 Akura Thrombectomy System?

Akura Thrombectomy System is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Akura Medical. The 510(k) number is K251070.

When was Akura Thrombectomy System approved by the FDA?

Akura Thrombectomy System received FDA 510(k) clearance on 2025-11-25, under approval number K251070.

What company makes Akura Thrombectomy System?

Akura Thrombectomy System is manufactured by Akura Medical.

What is the FDA product code for Akura Thrombectomy System?

The FDA product code for Akura 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

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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