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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 K120971
Device Name ATLAS PTA BALLOON DILATATION CATHETER
Original Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 west 3rd st.
tempe,  AZ  85281
Original Contact megan brown
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received04/02/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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