510(k) K090869

MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD by Medtronic Perfusion Systems — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2009
Date Received
March 31, 2009
Clearance Type
Traditional
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