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510(k) K230957

TriSalus TriNav® LV Infusion System by Trisalus Life Sciences — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2023
Date Received
April 4, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

Other clearances by Trisalus Life Sciences

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  • K193107 — TriSalus Infusion System (December 3, 2019)

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