Clearance Summary
VersaCross RF Wire received FDA 510(k) clearance under submission number K242076, sponsored by Baylis Medical Company. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-11-01.
- Submission: K242076
- Applicant / Sponsor: Baylis Medical Company
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5175
- Decision date: 2024-11-01
Classification & Regulation
This clearance is catalogued under FDA product code DXF and 21 CFR 870.5175, within the Cardiovascular review panel as a Class II device.