510(k) clearance

Cleerly ISCHEMIA

FDA 510(k) source

510(k) number

K262839

Applicant

Cleerly, Inc.

Decision date

Oct 29, 2026

Date received

Aug 11, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

QXZ

Device type

Adjunctive Epicardial Vascular Physiologic Status Indicator

Device class

Class II

Regulation

21 CFR 870.2200

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Denver, CO, US