FDA 510(k) Application Details - K111182

Device Classification Name	More FDA Info for this Device
510(K) Number	K111182
Device Name	ANGIOJET SOLENT OMNI THROMBECTOMY SET
Applicant	MEDRAD, INC. 9055 EVERGREEN BLVD NW MINNEAPOLIS, MN 55433-8003 US Other 510(k) Applications for this Company
Contact	Doug Atkins 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	04/27/2011
Decision Date	05/24/2011
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