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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K010169
Device Name BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
Applicant
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Applicant Contact CAROL VIERLING
Correspondent
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Correspondent Contact CAROL VIERLING
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received01/18/2001
Decision Date 02/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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