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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(K) Number K110643
Model U1SHC
Device Name MERIT MARQUIS FLOW SWITCH
Applicant
MERIT MEDICAL SYSTEMS, INC.
parkmore business park west
galway, 
Contact mark mullaney
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/04/2011
Decision Date 07/01/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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