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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 K121856
Device Name ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
Applicant
C.R. BARD, INC.
1625 west 3rd st.
tempe,  AZ  85281 1740
Contact erin fox
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/26/2012
Decision Date 07/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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