K250492
- 510(k) number
- K250492
- Device name
- FlexiGo 3D Delivery Catheter
- Applicant
- CenterPoint Systems, LLC UT · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2025-06-18
- Date received
- 2025-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K250492.pdf
Official FDA record: K250492
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.