Cleared Traditional

K253509 - TriSalus TriNav Advance Infusion System

K253509 is an FDA 510(k) clearance for TriSalus TriNav Advance Infusion System, manufactured by Trisalus Life Sciences. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K253509 · Trisalus Life Sciences · Cardiovascular device
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Sep 2026
Decision
320d
Days
Class 2
Risk

K253509 is an FDA 510(k) clearance for the TriSalus TriNav Advance Infusion System. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Trisalus Life Sciences (Westminster, US). The FDA issued a Cleared decision on September 21, 2026 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Trisalus Life Sciences devices

FDA 510(k) Submission Details - K253509

510(k) Number K253509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2025
Decision Date September 21, 2026
Days to Decision 320 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 125d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRA Catheter, Continuous Flush

All 161
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K253509.
Extroducer Infusion Catheter System
K254051 · SmartWise Sweden AB · Sep 2026
Verge™ Microcatheter
K261610 · Instylla, Inc. · Jun 2026
TruSelect™ 2.6 Microcatheter
K260771 · Boston Scientific Corporation · May 2026
InVera Infusion Device
K250794 · Invera Medical · Mar 2026
Micro Catheter
K243534 · Suzhou Zenith Vascular SciTech Limited · Jul 2025
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
K231821 · Transit Scientific, LLC · Nov 2023