SEU — Peripheral Temporary And Retrievable Stent System Class II
FDA product code SEU covers "Peripheral Temporary And Retrievable Stent System", a Class II medical device regulated under 21 CFR 870.5110. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SEU
- Device Class
- Class II
- Regulation Number
- 870.5110
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240048 | reflow medical | Spur Peripheral Retrievable Stent System | May 29, 2025 |