K243180
- 510(k) number
- K243180
- Device name
- SSPC NXT Delivery Catheter
- Applicant
- CenterPoint Systems, LLC UT · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-12-04
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K243180.pdf
Official FDA record: K243180
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.