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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K081523
Device Name EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Applicant
Abbott Vascular-Vascular Solutions
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact DANIELLE TAYLOR
Correspondent
Abbott Vascular-Vascular Solutions
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact DANIELLE TAYLOR
Regulation Number870.1250
Classification Product Code
NTE  
Date Received06/02/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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