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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 K181323
Device Name Atlas Gold PTA Dilatation Catheter
Applicant
C. R. Bard, Inc.
1625 West 3rd Street
Tempe,  AZ  85281
Applicant Contact Aaron Conovaloff
Correspondent
C. R. Bard, Inc.
1625 West 3rd Street
Tempe,  AZ  85281
Correspondent Contact Aaron Conovaloff
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received05/18/2018
Decision Date 08/03/2018
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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