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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 K073472
Device Name VACCESS PTA BALLOON DILATATION CATHETER
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact JENNIFER LOGVIN
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact JENNIFER LOGVIN
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received12/11/2007
Decision Date 01/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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