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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 K120164
Device Name PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
Original Applicant
ANGIOSLIDE, LTD
11925 w. i-70 frontage rd
north, ste 900
wheat ridge,  CO  80033
Original Contact clay anselmo
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received01/19/2012
Decision Date 06/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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