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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 K034058
Device Name SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
Applicant
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact PREETI JAIN
Correspondent
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact PREETI JAIN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/30/2003
Decision Date 01/29/2004
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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