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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 K080668
FOIA Releasable 510(k) K080668
Device Name G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
Applicant
C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281 -1740
Applicant Contact GENEVIEVE BALUTOWSKI
Correspondent
C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281 -1740
Correspondent Contact GENEVIEVE BALUTOWSKI
Regulation Number870.3375
Classification Product Code
DTK  
Date Received03/10/2008
Decision Date 07/30/2008
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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