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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 K121015
Device Name EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Applicant
Abbott Vascular
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact Ivalee Cohen
Correspondent
Abbott Vascular
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact Ivalee Cohen
Regulation Number870.1250
Classification Product Code
NTE  
Date Received04/04/2012
Decision Date 05/04/2012
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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