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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 K110909
Device Name EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..
Applicant
Abbott Laboratories
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact CHERECE L JONES
Correspondent
Abbott Laboratories
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact CHERECE L JONES
Regulation Number870.1250
Classification Product Code
NTE  
Date Received03/31/2011
Decision Date 04/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Clinical Trials NCT00402740
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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