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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 K052454
Device Name THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
Applicant
Abbott Vascular Devices
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact DEBBIE COGAN
Correspondent
Abbott Vascular Devices
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact DEBBIE COGAN
Regulation Number870.1250
Classification Product Code
NTE  
Date Received09/06/2005
Decision Date 09/14/2005
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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