Cleared Traditional

TriSalus TriGuideTM Guiding Catheter

K233858 · Trisalus Life Sciences · Cardiovascular
Dec 2023
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K233858 is an FDA 510(k) clearance for the TriSalus TriGuideTM Guiding Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Trisalus Life Sciences (Westminster, US). The FDA issued a Cleared decision on December 27, 2023, 22 days after receiving the submission on December 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K233858 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2023
Decision Date December 27, 2023
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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