Device Classification Name |
More FDA Info for this Device |
510(K) Number |
K071342 |
Device Name |
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 |
Applicant |
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 US
Other 510(k) Applications for this Company
|
Contact |
MARK STENOIEN
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 |
05/14/2007 |
Decision Date |
07/31/2007 |
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 |
|