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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 the device name listed in this FDA 510(k) record. The listed applicant is Akura Medical. It received FDA 510(k) clearance on 2025-11-25 under 510(k) 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. The listed applicant is Akura Medical. The 510(k) number is K251070.

When did Akura Thrombectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for Akura Thrombectomy System?

The FDA 510(k) record lists Akura Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Akura Thrombectomy System?

The FDA product code for Akura Thrombectomy System is QEW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06362928Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary EmbolismWITHDRAWNNCT06672510Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)SUSPENDEDNCT06152341Safety and Effectiveness of the ATC System in the Treatment of Acute PESUSPENDED

Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

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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