DeviceClearance

Product code SEU— Cardiovascular

Spur Peripheral Retrievable Stent System

Classification name
Peripheral Temporary And Retrievable Stent System
Device class
Class 2
Regulation
21 CFR 870.5110
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SEU under 21 CFR 870.5110, via openFDA

Market context for product code SEU

FDA has cleared 1 device under product code SEU, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SEU

Recent clearances under product code SEU

Data sourced from openFDA. This site is unofficial and independent of the FDA.