# K261800: Helo Max Thrombectomy System (HEL2090)

- Pathway: 510(k) (Traditional)
- Applicant: Endovascular Engineering
- Decided: Sep 3, 2026 after 94 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K901627 (1990). 83 ancestors in all.
No later device cites it as a predicate yet.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252956: Helo Thrombectomy System, Endovascular Engineering, Inc. (2025) Summary page 5.

## Indications for use
The Hélo Max Thrombectomy System is indicated for: The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature. The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. The Hēlo Max Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism.

Source page: https://510kreport.com/device/K261800
Methodology: https://510kreport.com/methodology