SEU — Peripheral Temporary And Retrievable Stent System Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
DEN240048reflow medicalSpur Peripheral Retrievable Stent SystemMay 29, 2025