FDA 510(k) Application Details - K093554

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K093554
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	JASON K LYON Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2009
Decision Date	04/13/2010
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