510(k) K253807 · MOD Accessory To Continuous Ventilator (Respirator)
Valence InVent Xtend (CVG-4101-VXA)
| Applicant | Convergence Medical Sciences , Ltd., Calgary, CA |
| Decision | Substantially Equivalent, Aug 20, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253807
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.