DQO · Class II · 21 CFR 870.1200

FDA Product Code DQO: Catheter, Intravascular, Diagnostic

FDA product code DQO covers diagnostic intravascular catheters used for hemodynamic assessment and angiography.

These catheters are advanced into heart chambers or vessels to measure intracardiac and intravascular pressures, sample blood for oxygen saturation, and inject contrast for angiographic imaging. They are used in cardiac catheterization laboratory diagnostic studies.

DQO devices are Class II medical devices, regulated under 21 CFR 870.1200 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Cordis Corp., Boston Scientific Corp and C.R. Bard, Inc..

500
Total
500
Cleared
122d
Avg days
1976
Since
Declining activity - 5 submissions in the last 2 years vs 9 in the prior period
Consistent review times: 140d avg (recent)

FDA 510(k) Cleared Catheter, Intravascular, Diagnostic Devices (Product Code DQO)

500 devices
1–24 of 500
Cleared May 28, 2026
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
K252702
Bioptimal International Pte. , Ltd.
Cardiovascular · 274d
Cleared Mar 25, 2026
Arterial Pressure Monitoring Set/Tray
K254278
Spectrum Vascular
Cardiovascular · 85d
Cleared Jul 17, 2025
DualView Catheter
K250751
Terumo Corporation
Cardiovascular · 127d
Cleared Jan 31, 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K242966
Gentuity, LLC
Cardiovascular · 127d
Cleared Nov 12, 2024
pNOVUS 21 Microcatheter
K242420
Phenox, Ltd.
Neurology · 89d
Cleared May 22, 2024
Impress Angiographic Catheter
K233268
Merit Medical Systems, Inc.
Cardiovascular · 236d
Cleared Apr 02, 2024
Zoom 6F Insert Catheters
K233975
Imperative Care, Inc.
Cardiovascular · 109d
Cleared Feb 23, 2024
Soldier Microcatheter
K232536
Embolx, Inc.
Cardiovascular · 186d
Cleared Nov 21, 2023
INFINITI™ Ambi Angiographic Catheter
K232573
Cordis US Corp
Cardiovascular · 88d
Cleared Aug 08, 2023
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
K230620
Gentuity, LLC
Cardiovascular · 155d
Cleared Jun 01, 2023
Drakon™ and Sequre® Microcatheters
K231293
Accurate Medical Therapeutics
Cardiovascular · 28d
Cleared Apr 14, 2023
Dragonfly OpStar™ Imaging Catheter
K230411
Abbott Medical
Cardiovascular · 58d
Cleared Nov 28, 2022
pNOVUS 21 Microcatheter
K221279
Phenox, Ltd.
Neurology · 209d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666
Pfm Medical, Inc.
Cardiovascular · 318d
Cleared Jun 17, 2022
Langston dual lumen catheter
K221470
Vascular Solutions, LLC
Cardiovascular · 28d
Cleared Feb 17, 2022
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
K212977
Cordis Corporation
Cardiovascular · 153d
Cleared Dec 21, 2021
Progreat Lambda
K211078
Terumo Clinical Supply Co., Ltd.
Cardiovascular · 253d
Cleared Dec 11, 2020
Drakon and Sequre Microcatheters
K203487
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 14d
Cleared Oct 23, 2020
Drakon and Sequre Microcatheters
K202797
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 30d
Cleared Jul 29, 2020
Superpipe Angiographic Catheter
K193647
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 212d
Cleared Dec 17, 2019
ILUMIEN System with AptiVue Software version D.3
K192267
Abbott Medical
Cardiovascular · 118d
Cleared Nov 22, 2019
Trevo Trak 21 Microcatheter
K192122
Stryker
Neurology · 108d
Cleared Nov 08, 2019
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
K192019
Abbott Medical
Cardiovascular · 102d
Cleared Aug 22, 2019
Bendit2.7 Steerable Microcatheter
K190126
Bend IT Technologies, Ltd.
Cardiovascular · 206d

About Product Code DQO - Regulatory Context

510(k) Submission Activity

500 total 510(k) submissions under product code DQO since 1976, with 500 receiving FDA clearance (average review time: 122 days).

Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 9 in the prior period.

FDA 510(k) Review Time - DQO Product Code

FDA review times for DQO submissions have been consistent, averaging 140 days recently vs 122 days historically.

DQO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →