FDA 510(k) Application Details - K110767

Device Classification Name	More FDA Info for this Device
510(K) Number	K110767
Device Name	ANGIOSCULPT PTA SCORING BALLOON CATHETER
Applicant	ANGIOSCORE, INC. 555 THIRTEENTH STREET NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN 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	03/18/2011
Decision Date	04/15/2011
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