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510(k) K193107

TriSalus Infusion System by Trisalus Life Sciences — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2019
Date Received
November 8, 2019
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

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