Valence InVent Xtend (CVG-4101-VXA)— 510(k) K253807

Name: FDA 510(k) clearance K253807
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Substantially Equivalent

Convergence Medical Sciences , Ltd.

FDA 510(k) clearance K253807 for Valence InVent Xtend (CVG-4101-VXA), Substantially Equivalent on 2026-08-20. Applicant: Convergence Medical Sciences , Ltd.. Device class: 2.

Clearance details

Applicant: Convergence Medical Sciences , Ltd.
Product code: Code MOD
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2025-11-28
Decision date: 2026-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, CA

Download summary PDF View on FDA.gov ↗

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