FDA 510(k) Application Details - K063785

Device Classification Name	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection   More FDA Info for this Device
510(K) Number	K063785
Device Name	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant	EV3 INC 9600 54TH AVENUE NORTH PLYMOUTH, MN 55442-2111 US Other 510(k) Applications for this Company
Contact	David Worrell Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NFA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2006
Decision Date	01/19/2007
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