FDA 510(k) Application Details - K153038

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K153038
Device Name	Syringe, Balloon Inflation
Applicant	MEDTRONIC, INC. 37A CHERRY HILL DRIVE DANVERS, MA 01923 US Other 510(k) Applications for this Company
Contact	NISARG SHAH 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	10/19/2015
Decision Date	04/13/2016
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review