FDA 510(k) Application Details - K251189

Device Classification Name	More FDA Info for this Device
510(K) Number	K251189
Device Name	Aventus Thrombectomy System
Applicant	Inquis Medical 1530 O'Brien Drive Suite A Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Zachary Woodson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2025
Decision Date	06/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review