SEU · Class II · 21 CFR 870.5110

FDA Product Code SEU: Peripheral Temporary And Retrievable Stent System

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.

Leading manufacturers include Reflow Medical, Inc..

1
Total
0
Cleared
251d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Peripheral Temporary And Retrievable Stent System Devices (Product Code SEU)

1 devices
1–1 of 1
Not Cleared May 29, 2025
Spur Peripheral Retrievable Stent System
DEN240048
Reflow Medical, Inc.
Cardiovascular · 251d

About Product Code SEU - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SEU since 2025, with 0 receiving FDA clearance (average review time: 251 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SEU devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →