Name: Predicase
Price: 199 USD

K-number	DEN240048
Device name	Spur Peripheral Retrievable Stent System
Applicant	Reflow Medical, Inc.
Product code	SEU
Device class	Class II
Decision date	May 29, 2025
Decision	Not Substantially Equivalent
Regulation	870.5110

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Spur Peripheral Retrievable Stent System

Everything you need for a 510(k) submission. Nothing you don't.