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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 K093659
Device Name ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85280
Applicant Contact Joni Creal
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85280
Correspondent Contact Joni Creal
Regulation Number870.3375
Classification Product Code
DTK  
Date Received11/25/2009
Decision Date 01/14/2010
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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