510(k) K253509
K253509 is an FDA 510(k) premarket notification submitted by Trisalus Life Sciences for the device "TriSalus TriNav Advance Infusion System". The FDA issued a decision of Substantially Equivalent on Sep 21, 2026. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Trisalus Life Sciences has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2026
- Date Received
- Nov 5, 2025
- 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
- 510(k)