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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 K153598
Device Name Medtronic Bio-Medicus Adult Cannula Kit
Applicant
MEDTRONIC INC.
8200 CORAL SEA STREET NE
MOUNDS VIEW,  MN  55112
Applicant Contact JENNIFER TANG
Correspondent
MEDTRONIC INC.
8200 CORAL SEA STREET NE
MOUNDS VIEW,  MN  55112
Correspondent Contact JENNIFER TANG
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/16/2015
Decision Date 01/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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