FDA 510(k) Application Details - K161786

Device Classification Name	More FDA Info for this Device
510(K) Number	K161786
Device Name	ClearLumen II Thrombectomy System
Applicant	Walk Vascular, LLC 17171 Daimler Street Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	David Look Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2016
Decision Date	10/18/2016
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review