Clearance Summary
ViaOne Epicardial Access System received FDA 510(k) clearance under submission number K243928, sponsored by Cardiovia , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-03-20.
- Submission: K243928
- Applicant / Sponsor: Cardiovia , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2025-03-20
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.