510(k) clearance

EnSite™ X EP System

FDA 510(k) source

510(k) number

K261729

Applicant

Abbott Medical

Decision date

Sep 17, 2026

Date received

May 26, 2026

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

St. Paul, MN, US