510(k) Report

FDA applicant

Trisalus Life Sciences

Westminster, CO4 decisions2019–20260 recalls

FDA records 4 decisions for Trisalus Life Sciences (Westminster, CO) from 2019 to 2026: 4 510(k) clearances. Most are in product codes KRA (Catheter, Continuous Flush) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 27 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Trisalus Life Sciences’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2019: 12023: 22026 (partial year): 1
2019high 2 (2023) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Trisalus Life Sciences by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Trisalus Life Sciences’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KRACatheter, Continuous Flush3decisions
  • DQYCatheter, Percutaneous1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 27 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 20231cites it

What has FDA decided for it lately?

  • K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
  • K233858TriSalus TriGuideTM Guiding CatheterTrisalus Life Sciences · 2023
  • K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023
  • K193107TriSalus Infusion SystemTrisalus Life Sciences · 2019

All 4 as Trisalus Life Sciences →