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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K960517
Device Name BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
Applicant
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Applicant Contact DONNA J WILSON
Correspondent
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Correspondent Contact DONNA J WILSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/05/1996
Decision Date 04/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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