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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 K231246
Device Name Ventrax™ Delivery System (VTR851)
Applicant
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Jenny Soderquist
Correspondent
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact Jenny Soderquist
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/01/2023
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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