510(k) clearance

Valence InVent Xtend™ (CVG-4101-VXA)

FDA 510(k) source

510(k) number

K253807

Applicant

Convergence Medical Sciences , Ltd.

Decision date

Aug 20, 2026

Date received

Nov 28, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MOD

Device type

Accessory To Continuous Ventilator (Respirator)

Device class

Class II

Regulation

21 CFR 868.5895

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

N

Location

Calgary, CA