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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K253509

510(k) cleared

TriSalus TriNav Advance Infusion System

Trisalus Life Sciences · Sep 21, 2026 · K253509 · In the directory

FDA cleared the TriSalus TriNav Advance Infusion System from Trisalus Life Sciences on Sep 21, 2026 under K253509, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code KRA, Catheter, Continuous Flush, regulated at 21 CFR 870.1210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 5, 2025. The decision came 320 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Trisalus Life Sciences in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253509?

K253509 is the FDA 510(k) for TriSalus TriNav Advance Infusion System, submitted by Trisalus Life Sciences. FDA's decision date was Sep 21, 2026, under product code KRA (Catheter, Continuous Flush).

Who makes the TriSalus TriNav Advance Infusion System?

Trisalus Life Sciences, based in Westminster, CO, is the applicant of record for K253509. The company is listed in the MedDevice Startups directory.

How long did the K253509 review take?

FDA received the submission on Nov 5, 2025 and issued its decision on Sep 21, 2026, 320 days later.

← All decisions in September 2026

Sources

In the startup directory

TriSalus Life Sciences

Oncology · Westminster, CO