FDA 510(k) Application Details - K014054

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K014054
Device Name	Catheter, Intravascular, Diagnostic
Applicant	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	JASON SMITH Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2001
Decision Date	03/08/2002
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