K252956 is an FDA 510(k) clearance for the Helo Thrombectomy System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.
Submitted by Endovascular Engineering, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 18, 2025 after a review of 93 days - within the typical 510(k) review window.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Endovascular Engineering, Inc. devices
NCT05597891
Completed
Interventional
Industry-sponsored
Endovascular Engineering ENGULF Study
A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
| Condition studied |
Pulmonary Embolism |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Andrew Klein, MD |
| Sponsor |
Endovascular Engineering
(industry)
|
Started 2023-01-12
→
Primary completion 2026-03-02
→
Completed 2026-03-30
Primary outcome
Primary Safety Objective
Study completed - no results published.
This trial concluded in 2026 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov