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FDA 510(k)

TriSalus Infusion System

K-Number: K193107 · 2019-12-03

ApplicantTrisalus Life Sciences
Decision Date2019-12-03
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TriSalus 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 2019-12-03 under 510(k) number K193107. 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 Infusion System?

TriSalus Infusion System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Trisalus Life Sciences. The 510(k) number is K193107.

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

TriSalus Infusion System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K193107.

Who is the listed applicant for TriSalus 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 Infusion System?

The FDA product code for TriSalus 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 CatheterK230957TriSalus TriNav® LV 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

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

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