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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 K062201
Device Name SPIDERX EMBOLIC PROTECTION DEVICE
Applicant
Ev3, Inc.
9600 54th Ave. N.
Plymouth,  MN  55442
Applicant Contact BRENDA JOHNSON
Correspondent
Ev3, Inc.
9600 54th Ave. N.
Plymouth,  MN  55442
Correspondent Contact BRENDA JOHNSON
Regulation Number870.1250
Classification Product Code
NFA  
Date Received08/01/2006
Decision Date 08/11/2006
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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