510(k) K061254

EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 by Medtronic Perfusion Systems — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
May 4, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type