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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 K120805
Device Name PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
Original Applicant
ANGIOSLIDE, LTD
11925 west i-70 frontage rd
north suite 900
clay anselmo,  CO  80033
Original Contact clay anselmo
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received03/16/2012
Decision Date 04/13/2012
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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