FDA 510(k) Application Details - K080806

Device Classification Name	More FDA Info for this Device
510(K) Number	K080806
Device Name	ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
Applicant	POSSIS MEDICAL, 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	03/21/2008
Decision Date	04/04/2008
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