FDA 510(k) Application Details - K192332

Device Classification Name	More FDA Info for this Device
510(K) Number	K192332
Device Name	ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
Applicant	Inari Medical 9272 Jeronimo Rd., 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	08/27/2019
Decision Date	09/20/2019
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