FDA 510(k) Application Details - K173266

Device Classification Name	More FDA Info for this Device
510(K) Number	K173266
Device Name	Octane aspiration system
Applicant	Vascular Solutions Inc. 6464 Sycamore Court North Minneapolis, MN 55369 US Other 510(k) Applications for this Company
Contact	Becky Astrup 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	10/11/2017
Decision Date	12/01/2017
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