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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 K993677
Device Name MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
Applicant
MEDTRONIC VASCULAR
620 WATSON STRET S.W.
GRAND RAPIDS,  MI  49504
Applicant Contact MICHAEL HINGSON
Correspondent
MEDTRONIC VASCULAR
620 WATSON STRET S.W.
GRAND RAPIDS,  MI  49504
Correspondent Contact MICHAEL HINGSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/01/1999
Decision Date 04/17/2000
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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