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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
510(k) Number K023303
Device Name EXPORT ASPIRATION CATHETER
Applicant
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact FRED L BOUCHER
Correspondent
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact FRED L BOUCHER
Regulation Number870.1250
Classification Product Code
NFA  
Date Received10/03/2002
Decision Date 10/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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