FDA 510(k) Application Details - K240117

Device Classification Name	More FDA Info for this Device
510(K) Number	K240117
Device Name	Aventus Thrombectomy System (IM-2001/IM-0002)
Applicant	Inquis Medical 127 Independence Drive Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Mojgan Saadat 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	01/16/2024
Decision Date	03/15/2024
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