CenterPoint Systems, LLC
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories4
Latest Approval2026-04-07
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K260942 | AuST Steerable Sheath | DYB | 2026-04-07 | View |
| 510(k) | K260163 | AuST CSP Introducer | DYB | 2026-02-19 | View |
| 510(k) | K250828 | CPS Locator 3D Plus Delivery Catheter | DQY | 2025-06-27 | View |
| 510(k) | K250492 | FlexiGo 3D Delivery Catheter | DQY | 2025-06-18 | View |
| 510(k) | K251051 | AuST Steerable Sheath | DYB | 2025-04-30 | View |
| 510(k) | K243180 | SSPC NXT Delivery Catheter | DQY | 2024-12-04 | View |
| 510(k) | K242106 | AuST Steerable Sheath | DYB | 2024-10-04 | View |
| 510(k) | K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps | FBN | 2024-05-02 | View |
| 510(k) | K240829 | AuST Steerable Sheath | DYB | 2024-05-01 | View |
| 510(k) | K223097 | RenaNav Ureteroscope System | FGB | 2023-07-31 | View |
| 510(k) | K230363 | CPS Locator 3D Delivery Catheter | DQY | 2023-03-09 | View |
| 510(k) | K210009 | Guiding Catheter | DQY | 2021-11-24 | View |
No matching devices.