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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 K132409
Device Name CONCIERGE GUIDING CATHETER
Applicant
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact VICKI GODWIN
Correspondent
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact VICKI GODWIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/02/2013
Decision Date 08/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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