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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(K) Number K120381
Device Name Q50 PLUS STENT GRAFT BALLOON CATHETER
Applicant
QXMEDICAL, LLC
1747 summit avenue
st. paul,  MN  55105
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
MJN  
Date Received02/07/2012
Decision Date 02/24/2012
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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