Clearance Summary
Falcon/Xpress (Falcon/Xpress) received FDA 510(k) clearance under submission number K242662, sponsored by Viasonix , 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 2024-12-18.
- Submission: K242662
- Applicant / Sponsor: Viasonix , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2880
- Decision date: 2024-12-18
Classification & Regulation
This clearance is catalogued under FDA product code JOP and 21 CFR 870.2880, within the Cardiovascular review panel as a Class II device.