FDA 510(k) Application Details - K113428

Device Classification Name	More FDA Info for this Device
510(K) Number	K113428
Device Name	ANGIOJET ULTRA DVX THROMBECTOMY SET
Applicant	MEDRAD, INC. 9055 EVERGREEN BLVD N.W. MINNEAPOLIS, MN 55433-8003 US Other 510(k) Applications for this Company
Contact	MIKE BURNSIDE 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	11/21/2011
Decision Date	12/02/2011
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
Expedited Review