Not Cleared Direct

DEN240048 - Spur Peripheral Retrievable Stent System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240048 · Reflow Medical, Inc. · Cardiovascular device
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May 2025
Decision
251d
Days
Class 2
Risk

DEN240048 is an FDA 510(k) submission (not cleared) for the Spur Peripheral Retrievable Stent System. Classified as Peripheral Temporary And Retrievable Stent System (product code SEU), Class II - Special Controls.

Submitted by Reflow Medical, Inc. (San Clemente, US). The FDA issued a Not Cleared (DENG) decision on May 29, 2025 after a review of 251 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5110 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 251 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Reflow Medical, Inc. devices

Submission Details

510(k) Number DEN240048 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 20, 2024
Decision Date May 29, 2025
Days to Decision 251 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 125d · This submission: 251d
Pathway characteristics

Device Classification

Product Code SEU Peripheral Temporary And Retrievable Stent System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5110
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.