Class Class II
CPS Locator 3D Plus Delivery Catheter (K250828)
Description
CPS Locator 3D Plus Delivery Catheter by CenterPoint Systems, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250828
Clearance Date2025-06-27
Clearance TypeSpecial
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250828
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. CPS Locator 3D Plus Delivery Catheter (K250828) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230363 | CPS Locator 3D Delivery Catheter | CenterPoint Systems, LLC | 2023 |
Trace the full predicate network for K250828
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.