TriSalus TriNav® LV Infusion System

Q: What is the product code of K230957?

The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.

FDA 510(k) K230957 · Trisalus Life Sciences

Substantially Equivalent

510(k) numberK230957

Submission

Device name: TriSalus TriNav® LV Infusion System
Applicant: Trisalus Life Sciences
Westminster, CO, US
Received: April 4, 2023
Decision date: May 2, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: KRA – Catheter, Continuous Flush
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1210
Specialty: Cardiovascular

Other 510(k)s with product code KRA

510(k)	Device	Applicant	Decision
K254051	Extroducer Infusion Catheter SystemKRA · Traditional	SmartWise Sweden AB	09/11/2026SE
K261610	Verge MicrocatheterKRA · Special	Instylla, Inc.	06/11/2026SE
K260771	TruSelect 2.6 MicrocatheterKRA · Special	Boston Scientific Corporation	05/15/2026SE
K250794	InVera Infusion DeviceKRA · Traditional	Invera Medical	03/12/2026SE
K243534	Micro CatheterKRA · Traditional	Suzhou Zenith Vascular SciTech Limited	07/30/2025SE
K231821	XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional	Transit Scientific, LLC	11/29/2023SE
K231279	Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional	Ablative Solutions, Inc.	07/05/2023SE
K231148	ScleroSafe 150 mm, ScleroSafe 350 mmKRA · Traditional	Vvt Medical , Ltd.	06/20/2023SE
K223139	Wallaby 017 Micro CatheterKRA · Traditional	Wallaby Medical	04/25/2023SE
K223176	Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus…KRA · Special	Argon Medical Devices, Inc.	04/10/2023SE

More from Argon Medical Devices, Inc.

510(k)	Device	Decision
K233858	TriSalus TriGuideTM Guiding CatheterDQY · Traditional	12/27/2023SE
K193107	TriSalus Infusion SystemKRA · Traditional	12/03/2019SE

Questions and answers

When was TriSalus TriNav® LV Infusion System cleared by the FDA?

TriSalus TriNav® LV Infusion System (K230957) received a 510(k) decision of Substantially Equivalent on May 2, 2023, 28 days after the submission was received.

What is the product code of K230957?

The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.