510(k) clearance

AVVIGO™+ Multi-Modality Guidance System

FDA 510(k) source

510(k) number

K253692

Applicant

Boston Scientific

Decision date

Aug 21, 2026

Date received

Nov 21, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DQK

Device type

Computer, Diagnostic, Programmable

Device class

Class II

Regulation

21 CFR 870.1425

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Maple Grove, MN, US