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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, percutaneous retrieval
510(K) Number K122088
Models PETITE SNARE KIT; ONE1001, ONE2501, STANDARD SNARE KIT;ONE500, ONE1000, ONE1500, ONE2000, ONE2500, ONE3000,ONE3500
Device Name MERIT ONE SNARE SYSTEM
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan,  UT  84095
Contact mark mullaney
Regulation Number870.5150
Classification Product Code
MMX  
Date Received07/16/2012
Decision Date 12/05/2012
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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