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FDA 510(k)

TriSalus TriGuideTM Guiding Catheter

K-Number: K233858 · 2023-12-27

ApplicantTrisalus Life Sciences
Decision Date2023-12-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TriSalus TriGuideTM Guiding Catheter 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 2023-12-27 under 510(k) number K233858. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TriSalus TriGuideTM Guiding Catheter?

TriSalus TriGuideTM Guiding Catheter is a medical device that received FDA 510(k) clearance on 2023-12-27. The listed applicant is Trisalus Life Sciences. The 510(k) number is K233858.

When did TriSalus TriGuideTM Guiding Catheter receive FDA 510(k) clearance?

TriSalus TriGuideTM Guiding Catheter received FDA 510(k) clearance on 2023-12-27, under 510(k) number K233858.

Who is the listed applicant for TriSalus TriGuideTM Guiding Catheter?

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 TriGuideTM Guiding Catheter?

The FDA product code for TriSalus TriGuideTM Guiding Catheter is DQY.

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.

K230957TriSalus TriNav® LV Infusion SystemK193107TriSalus Infusion System

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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