Cleared Traditional

DualView Catheter

K250751 · Terumo Corporation · Cardiovascular
Jul 2025
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K250751 is an FDA 510(k) clearance for the DualView Catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Terumo Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 17, 2025, 127 days after receiving the submission on March 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K250751 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2025
Decision Date July 17, 2025
Days to Decision 127 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
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
INFINITI? Ambi Angiographic Catheter
K232573 · Cordis US Corp · Nov 2023