K250492 is an FDA 510(k) clearance for the FlexiGo 3D Delivery Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on June 18, 2025, 118 days after receiving the submission on February 20, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K250492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2025 |
| Decision Date | June 18, 2025 |
| Days to Decision | 118 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |