510(k) K073559

18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II by Edwards Lifesciences Research Medical — Product Code DQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2008
Date Received
December 19, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Catheter
Device Class
Class II
Regulation Number
870.1300
Review Panel
CV
Submission Type