FDA 510(k) Application Details - DEN240048

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240048
Device Name	Spur Peripheral Retrievable Stent System
Applicant	Reflow Medical, Inc. 208 Avenida Fabricante, Suite 100 San Clemente, CA 92672 US Other 510(k) Applications for this Company
Contact	Lori Grace Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2024
Decision Date	05/29/2025
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review