CenterPoint Systems, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260163 | AuST CSP Introducer | February 19, 2026 |
| K250147 | CPS Locator 3D Delivery Catheter | August 22, 2025 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | June 27, 2025 |
| K250492 | FlexiGo 3D Delivery Catheter | June 18, 2025 |
| K251051 | AuST Steerable Sheath | April 30, 2025 |
| K243180 | SSPC NXT Delivery Catheter | December 4, 2024 |
| K242106 | AuST Steerable Sheath | October 4, 2024 |
| K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Ca | May 2, 2024 |
| K240829 | AuST Steerable Sheath | May 1, 2024 |
| K223097 | RenaNav Ureteroscope System | July 31, 2023 |
| K230363 | CPS Locator 3D Delivery Catheter | March 9, 2023 |
| K210009 | Guiding Catheter | November 24, 2021 |
| K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | June 28, 2019 |