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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K143208
Device Name Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
Applicant
C.R. Bard, Inc
1625 W. Third St.
Tempe,  AZ  85281
Applicant Contact Laurie Sang
Correspondent
C.R. Bard, Inc
1625 W. Third St.
Tempe,  AZ  85281
Correspondent Contact Laurie Sang
Regulation Number870.3375
Classification Product Code
DTK  
Date Received11/10/2014
Decision Date 12/09/2014
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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