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Helo Thrombectomy System

by Endovascular Engineering Inc.

510(k) K252956

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252956 Date18 Dec 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QEW
FDA applicant
Endovascular Engineering, Inc.
Device class
Class II
Regulation
21 CFR Part 870.5150
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Helo Thrombectomy System is a peripheral mechanical thrombectomy device with aspiration that features a self-expanding design with a unique funnel shape to ensure wide distal opening for effective large bore clot engagement. The system uses dual-action technology to break down and remove clot through combined high-speed agitation and simultaneous physician-controlled aspiration.

The device is supplied for single-use and is intended for use in cardiovascular procedures. It has received FDA 510(k) clearance with the product code QEW and is classified as a class II device. The system is designed for use in the treatment of pulmonary embolism and other vascular conditions where thrombectomy is indicated.

Other devices from Endovascular Engineering Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Helo Thrombectomy System intended for?

    The Helo Thrombectomy System is intended for use in cardiovascular procedures, specifically for the treatment of pulmonary embolism and other vascular conditions where thrombectomy is indicated, as stated in the device description.

  • How is the Helo Thrombectomy System supplied and is it reusable?

    The device is supplied for single-use only, meaning it is designed to be used once and then discarded, as explicitly stated in the device description under specifications.

  • What regulatory pathway was used for the Helo Thrombectomy System and what is its classification?

    The Helo Thrombectomy System received FDA 510(k) clearance and is classified as a class II device, as indicated in the device description and confirmed by the product code QEW and regulation number 870.5150.

  • What technology does the Helo Thrombectomy System use to remove clots?

    The system uses dual-action technology that combines high-speed agitation with simultaneous physician-controlled aspiration to break down and remove clot, as described in the device description.

  • What is the product code and device name for the Helo Thrombectomy System in the FDA database?

    The device has the product code QEW and the FDA device name 'Peripheral Mechanical Thrombectomy With Aspiration', as listed in the openfda field under device_name and product_code.