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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K242873
Device Name Ventrax™ Delivery System
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact Jenny Soderquist
Correspondent
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Jenny Soderquist
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/23/2024
Decision Date 01/15/2025
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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