K253807
- 510(k) number
- K253807
- Device name
- Valence InVent Xtend (CVG-4101-VXA)
- Applicant
- Convergence Medical Sciences , Ltd. CA
- Product code
- MOD — Accessory To Continuous Ventilator (Respirator)
- Decision date
- 2026-08-20
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253807.pdf
Official FDA record: K253807
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.