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FDA 510(k)

Helo™ Return

K-Number: K253717 · 2026-10-11

ApplicantEndovascular Engineering, Inc.
Decision Date2026-10-11
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Helo™ Return 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 2026-10-11 under 510(k) number K253717. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Helo™ Return?

Helo™ Return is a medical device that received FDA 510(k) clearance on 2026-10-11. The listed applicant is Endovascular Engineering, Inc.. The 510(k) number is K253717.

When did Helo™ Return receive FDA 510(k) clearance?

Helo™ Return received FDA 510(k) clearance on 2026-10-11, under 510(k) number K253717.

Who is the listed applicant for Helo™ Return?

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™ Return?

The FDA product code for Helo™ Return is CAC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

K252956Helo Thrombectomy System

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics 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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