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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(K) Number K122089
Model 3011
Device Name OSTIAL PRO STENT POSITIONING SYSTEM
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan,  UT  84095
Contact david thomas
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/16/2012
Decision Date 09/21/2012
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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