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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 K121265
Device Name AMPHIRION PLUS PTA CATHETER
Original Applicant
MEDTRONIC INC.
3576 unocal place
santa rosa,  CA  95403 1774
Original Contact nainesh sureja
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/26/2012
Decision Date 05/22/2012
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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