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510(k) DEN240048

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

DEN240048 is an FDA 510(k) premarket notification submitted by Reflow Medical, Inc. for the device "Spur Peripheral Retrievable Stent System". The FDA issued a decision of De Novo Granted on May 29, 2025. The device falls under product code SEU (Peripheral Temporary And Retrievable Stent System), a Class II device regulated under 21 CFR 870.5110. Reflow Medical, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Reflow Medical, Inc.

  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K233350 — SINC Support Catheter (February 8, 2024)
  • K210188 — coraCross (May 28, 2021)
  • K201811 — coraForce and coraFlex Support Catheters (October 26, 2020)
  • K200094 — speX LP Support Catheter (March 18, 2020)
  • K193596 — Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (February 20, 2020)
  • K193012 — speX Support Catheter (February 19, 2020)
  • K190393 — Wingman 14C Crossing Catheter (May 9, 2019)
  • K173661 — Wingman 35 Crossing Catheter (April 18, 2018)
  • K173662 — speX Support Catheter (December 20, 2017)

FDA data resources