Cleared Traditional

K253717 - Helo™ Return

K253717 · Endovascular Engineering, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
321d
Days
-
Risk

K253717 is an FDA 510(k) clearance for the Helo™ Return.

Submitted by Endovascular Engineering, Inc. (Menlo Park, US). The FDA issued a Cleared decision on October 11, 2026 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K253717

510(k) Number K253717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2025
Decision Date October 11, 2026
Days to Decision 321 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 125d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

SHJ Device Classification - Class ,

Product Code SHJ
Device Class -

Clinical Evidence

ClinicalTrials.gov
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)

177
Patients (actual)
21
Sites
Treatment
Purpose
Open label
Masking
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
K253717 · Helo™ Return
Download PDF FDA Summary Endovascular Engineer…