FDA 510(k) Application Details - K143563

Device Classification Name	More FDA Info for this Device
510(K) Number	K143563
Device Name	Infusion Aspiration Catheter System
Applicant	Inari Medical, Inc. 8 Argonaut Suite 100 Aliso Vejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Eben Gordon 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	12/16/2014
Decision Date	02/03/2015
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	Y
Expedited Review