FDA 510(k) Application Details - K140745

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K140745
Device Name	Syringe, Balloon Inflation
Applicant	BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 US Other 510(k) Applications for this Company
Contact	LISA MEE 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	03/25/2014
Decision Date	04/17/2014
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