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FDA 510(k)

TriSalus TriNav® LV Infusion System

K-Number: K230957 · 2023-05-02

ApplicantTrisalus Life Sciences
Decision Date2023-05-02
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TriSalus TriNav® LV Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Trisalus Life Sciences. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230957. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TriSalus TriNav® LV Infusion System?

TriSalus TriNav® LV Infusion System is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Trisalus Life Sciences. The 510(k) number is K230957.

When did TriSalus TriNav® LV Infusion System receive FDA 510(k) clearance?

TriSalus TriNav® LV Infusion System received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230957.

Who is the listed applicant for TriSalus TriNav® LV Infusion System?

The FDA 510(k) record lists Trisalus Life Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TriSalus TriNav® LV Infusion System?

The FDA product code for TriSalus TriNav® LV Infusion System is KRA.

Other records listing Trisalus Life Sciences as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233858TriSalus TriGuideTM Guiding CatheterK193107TriSalus Infusion System

Related Devices (Code: KRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO 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,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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