510(k) clearance

Mayumi™ Thrombectomy System

FDA 510(k) source

510(k) number

K254035

Applicant

MicroVention, Inc., d/b/a Terumo Neuro

Decision date

Sep 3, 2026

Date received

Dec 16, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QEZ

Device type

Aspiration Thrombectomy Catheter

Device class

Class II

Regulation

21 CFR 870.5150

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Aliso Viejo, CA, US