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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
Applicant
Merit Medical Systems, Inc.
1111 S. Velasco St.
Angleton,  TX  77515
Applicant Contact MICHAELA RIVKOWICH
Correspondent
Merit Medical Systems, Inc.
1111 S. Velasco St.
Angleton,  TX  77515
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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