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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 K121352
Device Name ARMADA 14XXT PTA CATHETER
Original Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara,  CA  95054
Original Contact ivalee cohen
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received05/17/2012
Decision Date 08/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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