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FDA 510(k)

Helo Thrombectomy System

K-Number: K252956 · 2025-12-18

ApplicantEndovascular Engineering, Inc.
Decision Date2025-12-18
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Helo Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Endovascular Engineering, Inc.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252956. 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 Helo Thrombectomy System?

Helo Thrombectomy System is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Endovascular Engineering, Inc.. The 510(k) number is K252956.

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

Helo Thrombectomy System received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252956.

Who is the listed applicant for Helo Thrombectomy System?

The FDA 510(k) record lists Endovascular Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helo Thrombectomy System?

The FDA product code for Helo Thrombectomy System is QEW.

Other records listing Endovascular Engineering, Inc. as applicant

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.

K223891Cobra Catheter System

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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