Clearance Summary
CorVision® (91-205-Z0014) received FDA 510(k) clearance under submission number K260051, sponsored by CorVent® Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-05-12.
- Submission: K260051
- Applicant / Sponsor: CorVent® Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2026-05-12
Classification & Regulation
This clearance is catalogued under FDA product code MOD and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.