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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 K052165
Device Name RX ACCUNET EMBOLIC PROTECTION SYSTEM
Applicant
GUIDANT CORPORATION
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact JULIA ANASTAS
Correspondent
GUIDANT CORPORATION
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact JULIA ANASTAS
Regulation Number870.1250
Classification Product Code
NTE  
Date Received08/09/2005
Decision Date 08/16/2005
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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