FDA 510(k) Application Details - K182232

Device Classification Name	More FDA Info for this Device
510(K) Number	K182232
Device Name	Octane Mechanical Thrombectomy System
Applicant	Vascular Solutions, Inc. 6401 Sycamore Ct N Maple Grove, MN 55369 US Other 510(k) Applications for this Company
Contact	Iroquois Ledbeter 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	08/17/2018
Decision Date	09/11/2018
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