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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 K230957
Device Name TriSalus TriNav® LV Infusion System
Applicant
TriSalus Life Sciences
6272 W. 91st Avenue
Westminster,  CO  80031
Applicant Contact Michael Aymami
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
DQO  
Date Received04/04/2023
Decision Date 05/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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