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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 K130366
Device Name BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
Applicant
C.R Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Joni Creal
Correspondent
C.R Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Joni Creal
Regulation Number870.3375
Classification Product Code
DTK  
Date Received02/13/2013
Decision Date 05/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01305564
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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