Helo Thrombectomy System— 510(k) K252956

Name: FDA 510(k) clearance K252956
Creator: U.S. Food and Drug Administration
Published: 2025-12-18

Substantially Equivalent

Endovascular Engineering, Inc.

FDA 510(k) clearance K252956 for Helo Thrombectomy System, Substantially Equivalent on 2025-12-18. Applicant: Endovascular Engineering, Inc.. Device class: 2.

Clearance details

Applicant: Endovascular Engineering, Inc.
Product code: Code QEW
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2025-09-16
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEW

view all

K261800 — Helo Max Thrombectomy System (HEL2090)2026-09-03
K262538 — Artix MT; Artix Thin-Walled Sheath2026-08-21
K261523 — Vertex Thrombectomy System2026-08-04
K260599 — INDIGO® Aspiration System INDIGO Link2026-04-24
K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK2026-02-05

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.