DEN240048 is an FDA 510(k) submission for the Spur Peripheral Retrievable Stent System. This device is classified as a Peripheral Temporary And Retrievable Stent System (Class II - Special Controls, product code SEU).
Submitted by Reflow Medical, Inc. (San Clemente, US). The FDA issued a Not Cleared (DENG) decision on May 29, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5110. A Peripheral Temporary And Retrievable Stent System Is A Temporary Scaffold Placed Into The Peripheral Vasculature Via A Delivery Catheter System For Treating Stenotic Lesions. The Device Is Designed To Be Retrieved And Removed Following Successful Treatment..
| 510(k) Number | DEN240048 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 20, 2024 |
| Decision Date | May 29, 2025 |
| Days to Decision | 251 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | SEU - Peripheral Temporary And Retrievable Stent System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5110 |
| Definition | A Peripheral Temporary And Retrievable Stent System Is A Temporary Scaffold Placed Into The Peripheral Vasculature Via A Delivery Catheter System For Treating Stenotic Lesions. The Device Is Designed To Be Retrieved And Removed Following Successful Treatment. |