FDA 510(k) Application Details - K163549

Device Classification Name	More FDA Info for this Device
510(K) Number	K163549
Device Name	ClotTriever Thrombectomy System
Applicant	Inari Medical, Inc. 9272 Jeronimo Road Suite 124 Irvine, CA 92618 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	12/16/2016
Decision Date	02/16/2017
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