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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K031518
Device Name EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
Applicant
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact DAWN STENSTROM
Correspondent
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact DAWN STENSTROM
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/15/2003
Decision Date 05/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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