SEUClass II
Peripheral Temporary And Retrievable Stent System
21 CFR 870.5110 / Cardiovascular
SEU is the FDA product code for Peripheral Temporary And Retrievable Stent System, a class II device type, regulated under 21 CFR 870.5110. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SEU
- Device name
- Peripheral Temporary And Retrievable Stent System
- 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.
- Regulation
- 21 CFR 870.5110
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SEU
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SEU| Applicant | Clearances |
|---|---|
| ReFlow Medical, Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.