FDA 510(k) Application Details - K183198

Device Classification Name	More FDA Info for this Device
510(K) Number	K183198
Device Name	FlowTriever Retrieval/Aspiration System
Applicant	Inari Medical 9272 Jeronimo Rd., Suite 124 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Eben Gordan 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	11/19/2018
Decision Date	12/17/2018
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