Peripheral Temporary And Retrievable Stent System
A peripheral temporary and retrievable stent system is a cardiovascular device that temporarily scaffolds stenotic lesions in the peripheral vasculature via a delivery catheter system, designed to be retrieved and removed following successful treatment, offering the hemodynamic benefit of stenting without permanent implantation. It is classified as FDA Class II (510(k) required) under regulation 870.5110 in the Cardiovascular specialty, with product code SEU. The device is not classified as an implant (due to its retrievable nature) and does not support life-sustaining functions.
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Basic Information
- Product Code
- SEU
- Device Class
- FDA class 2
- Regulation Number
- 870.5110
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240048 | Spur Peripheral Retrievable Stent System | May 29, 2025 | Unknown | Reflow Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.