FDA 510(k) Application Details - K251488

Device Classification Name	More FDA Info for this Device
510(K) Number	K251488
Device Name	FLOWRUNNER Aspiration System
Applicant	Expanse Medical Inc. 7060 Koll Canter Parkway Suite 300 Pleasanton, CA 94566 US Other 510(k) Applications for this Company
Contact	Shiva Ardakani Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2025
Decision Date	07/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review