FDA 510(k) Application Details - K080765

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K080765
Device Name	Wire, Guide, Catheter
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	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2008
Decision Date	06/20/2008
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