FDA 510(k) Application Details - K070951

Device Classification Name	More FDA Info for this Device
510(K) Number	K070951
Device Name	2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
Applicant	BOSTON SCIENTIFIC 3574 RUFFIN RD. SAN DIEGO, CA 92123 US Other 510(k) Applications for this Company
Contact	BRIAN PARK 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	04/04/2007
Decision Date	06/04/2007
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