510(k) clearance

Aristotle 65 Macrowire

FDA 510(k) source

510(k) number

K254181

Applicant

Scientia Vascular

Decision date

Sep 16, 2026

Date received

Dec 23, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MOF

Device type

Guide, Wire, Catheter, Neurovasculature

Device class

Class II

Regulation

21 CFR 870.1330

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

West Valley City, UT, US