FDA 510(k) Application Details - K181877

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K181877
Device Name	Catheter, Peripheral, Atherectomy
Applicant	Volcano AtheroMed Inc. 1530 O'Brien Drive Suite A Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Jean Chang 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	07/13/2018
Decision Date	12/17/2018
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