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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
Applicant
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact JOHN W NICHOLSON
Correspondent
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact JOHN W NICHOLSON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/23/2003
Decision Date 10/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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