FDA 510(k) Application Details - K090621

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K090621
Device Name	Injector And Syringe, Angiographic
Applicant	FLOWCARDIA, INC. 745 N. PASTORIA AVE. SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	Dustin Michaels Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2009
Decision Date	06/19/2009
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