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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 K160866
Device Name Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian 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 Received03/30/2016
Decision Date 04/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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