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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 K053171
Device Name MERIT IMPRESS DIAGNOSTIC CATHETER
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan,  UT  84095
Contact stephanie erskine
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/14/2005
Decision Date 01/19/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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