FDA 510(k) Application Details - K122152

Device Classification Name	Syringe, Balloon Inflation   More FDA Info for this Device
510(K) Number	K122152
Device Name	Syringe, Balloon Inflation
Applicant	OXTI CORPORATION 7128 STAFFORDSHIRE STREET HOUSTON, TX 77030 US Other 510(k) Applications for this Company
Contact	JOSEPH J CHANG 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	07/20/2012
Decision Date	12/14/2012
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