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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 K994171
Device Name MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
Applicant
MEDTRONIC CARDIAC SURGICAL PRODUCTS
620 WATSON S.W.
GRAND RAPIDS,  MI  49504
Applicant Contact JAMES BALUN
Correspondent
MEDTRONIC CARDIAC SURGICAL PRODUCTS
620 WATSON S.W.
GRAND RAPIDS,  MI  49504
Correspondent Contact JAMES BALUN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/10/1999
Decision Date 04/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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