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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 K013013
Device Name MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
Applicant
MEDTRONIC CARDIAC SURGICAL PRODUCTS
620 WATSON SW
GRAND RAPIDS,  MI  49504 -6393
Applicant Contact ROGER W BRINK
Correspondent
MEDTRONIC CARDIAC SURGICAL PRODUCTS
620 WATSON SW
GRAND RAPIDS,  MI  49504 -6393
Correspondent Contact ROGER W BRINK
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/07/2001
Decision Date 12/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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