510(k) clearance

Affera Integrated Mapping System

FDA 510(k) source

510(k) number

K262005

Applicant

Medtronic, Inc.

Decision date

Aug 21, 2026

Date received

Jun 15, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Mounds View, MN, US