SEU

Peripheral Temporary And Retrievable Stent System

Product code
SEU
Device name
Peripheral Temporary And Retrievable Stent System
Device class
Class 2
21 CFR
21 CFR 870.5110
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-05-29.

NumberDecision dateApplicantDevice nameSummary
DEN2400482025-05-29Reflow Medical, Inc.Spur Peripheral Retrievable Stent System
Official FDA classification page: SEU
Classification and pathway per current FDA publications. Data from openFDA (CC0).