Clearance Summary
Elfor-L received FDA 510(k) clearance under submission number K243852, sponsored by Elfi-Tech , 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 2025-04-14.
- Submission: K243852
- Applicant / Sponsor: Elfi-Tech , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2025-04-14
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.