FDA 510(k) Application Details - K172386

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K172386
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 Chnag 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	08/08/2017
Decision Date	08/24/2017
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
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