# DEN240048: Spur Peripheral Retrievable Stent System

- Pathway: De Novo (Direct)
- Applicant: Reflow Medical, Inc.
- Decided: May 29, 2025 after 251 days
- Product code: SEU (Peripheral Temporary And Retrievable Stent System)
- Device class: 2
- Regulation: 21 CFR 870.5110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Spur® Peripheral Retrievable Stent System is intended as an adjunct to percutaneous transluminal angioplasty (PTA) to dilate stenoses in infrapopliteal arteries ranging in diameter from 2.5 mm to 4.5 mm.

Source page: https://510kreport.com/device/DEN240048
Methodology: https://510kreport.com/methodology