FDA 510(k) Application Details - K182835

Device Classification Name	More FDA Info for this Device
510(K) Number	K182835
Device Name	WOLF Thrombectomy Device
Applicant	880 Medical, LLC 46714 Fremont Blvd. Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Micheal P. Wallace 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	10/09/2018
Decision Date	03/27/2019
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