FDA 510(k) Application Details - K040155

Device Classification Name	More FDA Info for this Device
510(K) Number	K040155
Device Name	PERIPHERAL CUTTING BALLOON
Applicant	BOSTON SCIENTIFIC CORP. 3574 RUFFIN ROAD SAN DIEGO, CA 92123 US Other 510(k) Applications for this Company
Contact	RENUKA KRISHNAN 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	01/23/2004
Decision Date	07/01/2004
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