FDA 510(k) Application Details - K133399

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K133399
Device Name	Catheter, Peripheral, Atherectomy
Applicant	CARDIOVASCULAR SYSTEMS INCORPORATED 651 CAMPUS DR. SAINT PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	BLAIR BUTH 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	11/06/2013
Decision Date	11/22/2013
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