FDA 510(k) Application Details - K053195

Device Classification Name	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection   More FDA Info for this Device
510(K) Number	K053195
Device Name	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant	EV3 INC. 4600 NATHAN LN. NORTH PLYMOUTH, MN 55442-2920 US Other 510(k) Applications for this Company
Contact	BRENDA JOHNSON 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	11/15/2005
Decision Date	06/23/2006
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