Clearance Summary
LC Bead LUMI received FDA 510(k) clearance under submission number K152157, sponsored by Biocompatibles UK , 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 2015-12-11.
- Submission: K152157
- Applicant / Sponsor: Biocompatibles UK , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3300
- Decision date: 2015-12-11
Classification & Regulation
This clearance is catalogued under FDA product code KRD and 21 CFR 870.3300, within the Cardiovascular review panel as a Class II device.