SEU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Peripheral Temporary And Retrievable Stent System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5110
- Medical specialty
- Cardiovascular
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Spur Peripheral Retrievable Stent System (DEN240048) | Reflow Medical, Inc. | 2025-05-29 |
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