Cleared Traditional

Gentuity? HF-OCT Imaging System with Vis-Rx? Micro-Imaging Catheter

K230620 · Gentuity, LLC · Cardiovascular
Aug 2023
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K230620 is an FDA 510(k) clearance for the Gentuity? HF-OCT Imaging System with Vis-Rx? Micro-Imaging Catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Gentuity, LLC (Sudbury, US). The FDA issued a Cleared decision on August 8, 2023, 155 days after receiving the submission on March 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K230620 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2023
Decision Date August 08, 2023
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

Similar Devices — DQO Catheter, Intravascular, Diagnostic

All 497
DualView Catheter
K250751 · Terumo Corporation · Jul 2025
Gentuity? HF-OCT Imaging System with Vis-Rx Prime? Micro-Imaging Catheter
K242966 · Gentuity, LLC · Jan 2025
pNOVUS 21 Microcatheter
K242420 · Phenox, Ltd. · Nov 2024
Impress Angiographic Catheter
K233268 · Merit Medical Systems, Inc. · May 2024
Zoom 6F Insert Catheters
K233975 · Imperative Care, Inc. · Apr 2024
Soldier Microcatheter
K232536 · Embolx, Inc. · Feb 2024