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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K082143
Device Name MICRO GUIDE CATHETER XP
Applicant
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
Cordis Corp.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number870.1250
Classification Product Code
PDU  
Date Received07/30/2008
Decision Date 08/25/2008
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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