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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 K193107
Device Name TriSalus Infusion System
Applicant
Trisalus Life Sciences
6272 W. 91st Ave.
Westminster,  CO  80031
Applicant Contact Patrick McCain
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
DQO  
Date Received11/08/2019
Decision Date 12/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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