FDA 510(k) Application Details - K132682

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K132682
Device Name	Catheter, Peripheral, Atherectomy
Applicant	ATHEROMED INC 1455 ADAMS DRIVE SUITE 1110 MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	ELISA HEBB 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	08/28/2013
Decision Date	01/17/2014
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