FDA 510(k) Application Details - K003992

Device Classification Name	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection   More FDA Info for this Device
510(K) Number	K003992
Device Name	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant	PERCUSURGE, INC. 540 OAKMEAD PKWY. SUNNYVALE, CA 94086 US Other 510(k) Applications for this Company
Contact	MATTHEW J MOON 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	12/26/2000
Decision Date	06/01/2001
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