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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 K121051
Device Name CONCIERGE GUIDING CATHETER
Original Applicant
MERIT MEDICAL SYSTEMS, INC.
1111 south velasco st
angleton,  TX  77515
Original Contact michaela rivkowich
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/06/2012
Decision Date 06/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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