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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 a medical device manufactured by Trisalus Life Sciences. It received FDA 510(k) clearance on 2023-12-27 under approval 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. It is manufactured by Trisalus Life Sciences. The 510(k) number is K233858.

When was TriSalus TriGuideTM Guiding Catheter approved by the FDA?

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

What company makes TriSalus TriGuideTM Guiding Catheter?

TriSalus TriGuideTM Guiding Catheter is manufactured by Trisalus Life Sciences.

What is the FDA product code for TriSalus TriGuideTM Guiding Catheter?

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

Related Clinical Trials

NCT07531368 BBAP With CS Mapping Guidance NOT_YET_RECRUITING

Other Devices by Trisalus Life Sciences

K193107TriSalus Infusion System K230957TriSalus TriNav® LV Infusion System

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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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