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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 K131269
Device Name DLP CORONARY OSTIAL PERFUSION CANNULAE
Applicant
MEDTRONIC, INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact KEVIN T LAM
Correspondent
MEDTRONIC, INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact KEVIN T LAM
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/03/2013
Decision Date 07/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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