510(k) clearance

Evident Vascular™ Guidance System

FDA 510(k) source

510(k) number

K261648

Applicant

Evident Vascular, Inc.

Decision date

Oct 28, 2026

Date received

May 18, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IYO

Device type

System, Imaging, Pulsed Echo, Ultrasonic

Device class

Class II

Regulation

21 CFR 892.1560

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

San Jose, CA, US