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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 K202610
Device Name Ventrax Delivery System
Applicant
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Elizabeth Lazaro
Correspondent
Merit Medical Systems, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact Elizabeth Lazaro
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/09/2020
Decision Date 12/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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