FDA 510(k) Application Details - K080151

Device Classification Name	More FDA Info for this Device
510(K) Number	K080151
Device Name	ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
Applicant	ANGIOSCORE, INC. 5055 BRANDIN COURT FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	KARIN J GASTINEAU Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2008
Decision Date	04/25/2008
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