FDA 510(k) Application Details - K123482

Device Classification Name	More FDA Info for this Device
510(K) Number	K123482
Device Name	REFLOW ASPIRATION CATHETER
Applicant	VOLCANO CORPORATION 3661 VALLEY CENTER DR SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	BRIAN PARK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2012
Decision Date	04/29/2013
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