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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 K031922
Device Name CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
Original Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan,  UT  84095
Original Contact john w nicholson
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/23/2003
Decision Date 10/01/2003
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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