CorVision® (91-205-Z0014)— 510(k) K260051
Substantially EquivalentCorVent® Medical, Inc.
FDA 510(k) clearance K260051 for CorVision® (91-205-Z0014), Substantially Equivalent on 2026-05-12. Applicant: CorVent® Medical, Inc.. Device class: 2.
Summary
CorVent Medical's CorVision (91-205-Z0014) is filed under MOD, accessories to continuous ventilators (respirators).
Class II, 21 CFR 868.5895. Anesthesiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
CorVent filed from Fargo, North Dakota. The decision came 124 calendar days after receipt (January 8 to May 12, 2026).
Clearance details
- Applicant
- CorVent® Medical, Inc.
- 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
- Fargo, ND, US
Recent devices under product code MOD
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