LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (K252645)
Description
LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub by Philips Medical Systems Nederland B.V., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252645
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (K252645) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2024 |
Trace the full predicate network for K252645
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.