Clearance Summary
LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub received FDA 510(k) clearance under submission number K252645, sponsored by Philips Medical Systems Nederland B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-10-24.
- Submission: K252645
- Applicant / Sponsor: Philips Medical Systems Nederland B.V.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2025-10-24
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.