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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K193082
Device Name Fountain ValveTip Infusion Catheter
Applicant
Merit Medical Systems, Inc
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact Spriha Pandey
Correspondent
Merit Medical Systems, Inc
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Spriha Pandey
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/05/2019
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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