FDA 510(k) Application Details - K061951

Device Classification Name	More FDA Info for this Device
510(K) Number	K061951
Device Name	ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120
Applicant	POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. MINNEAPOLIS, MN 55433-8003 US Other 510(k) Applications for this Company
Contact	FRANK B FREEDMAN 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	07/10/2006
Decision Date	11/22/2006
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