Valence InVent Xtend (CVG-4101-VXA)— 510(k) K253807
Substantially EquivalentConvergence 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.
Summary
Convergence Medical Sciences filed the Valence InVent Xtend, model CVG-4101-VXA, under product code MOD, accessories to continuous ventilators (respirators).
Class II, 21 CFR 868.5895. Anesthesiology is both the classification panel and the review panel. It was a Traditional 510(k).
The applicant filed from Calgary, Canada. The decision came 265 calendar days after FDA received it (November 28, 2025 to August 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Convergence Medical Sciences , Ltd.
- Product code
- Product code MOD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calgary, CA
Recent devices under product code MOD
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