K-number	K251070
Device name	Akura Thrombectomy System
Applicant	Akura Medical
Product code	QEW
Device class	Class II
Decision date	Nov 25, 2025
Decision	Substantially Equivalent
Regulation	870.5150

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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Akura Thrombectomy System

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