Helo Max Thrombectomy System (HEL2090)— 510(k) K261800
Substantially EquivalentEndovascular Engineering
FDA 510(k) clearance K261800 for Helo Max Thrombectomy System (HEL2090), Substantially Equivalent on 2026-09-03. Applicant: Endovascular Engineering. Device class: 2.
Summary
The Helo Max Thrombectomy System (HEL2090) from Endovascular Engineering is filed under QEW, peripheral mechanical thrombectomy with aspiration. The record gives nothing beyond the model number and code name.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Endovascular Engineering filed from Menlo Park, California. The decision came 94 calendar days after receipt (June 1 to September 3, 2026).
Clearance details
- Applicant
- Endovascular Engineering
- Product code
- Product code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code QEW
view allMore clearances from Endovascular Engineering
view allAdverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
Source: openFDA MAUDE database, through . 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.