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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 K042908
Device Name RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
Applicant
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054 -2807
Applicant Contact VIRGINIA SINGER
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054 -2807
Correspondent Contact VIRGINIA SINGER
Regulation Number870.1250
Classification Product Code
NTE  
Date Received10/21/2004
Decision Date 11/12/2004
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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