FDA 510(k) Application Details - K180416

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K180416
Device Name	Catheter, Peripheral, Atherectomy
Applicant	Cardiovascular Systems Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112 US Other 510(k) Applications for this Company
Contact	Susan Wolf 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	02/15/2018
Decision Date	04/17/2018
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