FDA 510(k) Application Details - K130381

Device Classification Name	More FDA Info for this Device
510(K) Number	K130381
Device Name	ANGIOJET ULTRA POWER PULSE KIT
Applicant	MEDRAD, INC. 9055 EVERGREEN BLVD NW MINNEAPOLIS, MN 55433-8003 US Other 510(k) Applications for this Company
Contact	AMRA RACIC Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2013
Decision Date	07/29/2013
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