FDA 510(k) Application Details - K090253

Device Classification Name	More FDA Info for this Device
510(K) Number	K090253
Device Name	ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
Applicant	POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. 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	02/02/2009
Decision Date	04/08/2009
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