K250828
- 510(k) number
- K250828
- Device name
- CPS Locator 3D Plus Delivery Catheter
- Applicant
- CenterPoint Systems, LLC UT · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-06-27
- Date received
- 2025-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K250828.pdf
Official FDA record: K250828
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.