FDA 510(k) Application Details - K111388

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K111388
Device Name	Catheter, Peripheral, Atherectomy
Applicant	CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	MEGAN M BRANDT Other 510(k) Applications for this Contact
Regulation Number	870.4875   More FDA Info for this Regulation Number
Classification Product Code	MCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2011
Decision Date	07/26/2011
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