510(k) DEN240048

Spur Peripheral Retrievable Stent System by Reflow Medical, Inc. — Product Code SEU

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 29, 2025
Date Received: September 20, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Peripheral Temporary And Retrievable Stent System
Device Class: Class II
Regulation Number: 870.5110
Review Panel: CV
Submission Type

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.

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K193012 — speX Support Catheter (February 19, 2020)
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K173662 — speX Support Catheter (December 20, 2017)