510(k) clearance

Helo™ Return

FDA 510(k) source

510(k) number

K253717

Applicant

Endovascular Engineering, Inc.

Decision date

Oct 11, 2026

Date received

Nov 24, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

SHJ

Device type

Thrombectomy Whole Blood Return System

Device class

Class II

Regulation

21 CFR 868.5830

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

N

Location

Menlo Park, CA, US