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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 K042218
Device Name ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
Applicant
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact LARAINE PANGELINA
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact LARAINE PANGELINA
Regulation Number870.1250
Classification Product Code
NTE  
Date Received08/05/2004
Decision Date 08/31/2004
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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