FDA 510(k) Application Details - K961471

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K961471
Device Name	Syringe, Balloon Inflation
Applicant	ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. SANTA CLARA, CA 95052-8167 US Other 510(k) Applications for this Company
Contact	GARY JOHNSON 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	04/17/1996
Decision Date	05/08/1996
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