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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(K) Number K122190
Model PSS-7F-11-038
Device Name PRELUDE 7F SHORT SHEATH INTRODUCER
Applicant
MERIT MEDICAL SYSTEMS, INC.
1111 south velasco st
angleton,  TX  77515
Contact dan clark
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/24/2012
Decision Date 08/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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