FDA 510(k) Application Details - K110103

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K110103
Device Name	Catheter, Intravascular, Diagnostic
Applicant	EDWARDS LIFESCIENCES LLC 12050 LONE PEAK PARKWAY DRAPER, UT 84020-0000 US Other 510(k) Applications for this Company
Contact	SPENCER WALKER 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	01/13/2011
Decision Date	02/11/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review