FDA 510(k) Application Details - K152387

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K152387
Device Name	Syringe, Balloon Inflation
Applicant	VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 US Other 510(k) Applications for this Company
Contact	BEKA VITE Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	MAV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2015
Decision Date	12/18/2015
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review