Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200) → DQO — Catheter, Intravascular, Diagnostic

# DQO · Catheter, Intravascular, Diagnostic

_Cardiovascular · 21 CFR 870.1200 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/DQO

## Overview

- **Product Code:** DQO
- **Device Name:** Catheter, Intravascular, Diagnostic
- **Regulation:** [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 500)

Showing 20 most recent of 500 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252702](/device/K252702.md) | 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 | Bioptimal International Pte. , Ltd. | May 28, 2026 | SESE |
| [K254278](/device/K254278.md) | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Mar 25, 2026 | SESE |
| [K250751](/device/K250751.md) | DualView Catheter | Terumo Corporation | Jul 17, 2025 | SESE |
| [K242966](/device/K242966.md) | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | Jan 31, 2025 | SESE |
| [K242420](/device/K242420.md) | pNOVUS 21 Microcatheter | Phenox, Ltd. | Nov 12, 2024 | SESE |
| [K233268](/device/K233268.md) | Impress Angiographic Catheter | Merit Medical Systems, Inc. | May 22, 2024 | SESE |
| [K233975](/device/K233975.md) | Zoom 6F Insert Catheters | Imperative Care, Inc. | Apr 2, 2024 | SESE |
| [K232536](/device/K232536.md) | Soldier Microcatheter | Embolx, Inc. | Feb 23, 2024 | SESE |
| [K232573](/device/K232573.md) | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp | Nov 21, 2023 | SESE |
| [K230620](/device/K230620.md) | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | Aug 8, 2023 | SESE |
| [K231293](/device/K231293.md) | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics | Jun 1, 2023 | SESE |
| [K230411](/device/K230411.md) | Dragonfly OpStar™ Imaging Catheter | ABBOTT MEDICAL | Apr 14, 2023 | SESE |
| [K221279](/device/K221279.md) | pNOVUS 21 Microcatheter | Phenox, Ltd. | Nov 28, 2022 | SESE |
| [K213666](/device/K213666.md) | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | Oct 6, 2022 | SESE |
| [K221470](/device/K221470.md) | Langston dual lumen catheter | Vascular Solutions, LLC | Jun 17, 2022 | SESE |
| [K212977](/device/K212977.md) | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | Feb 17, 2022 | SESE |
| [K211078](/device/K211078.md) | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | Dec 21, 2021 | SESE |
| [K203487](/device/K203487.md) | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | Dec 11, 2020 | SESE |
| [K202797](/device/K202797.md) | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | Oct 23, 2020 | SESE |
| [K193647](/device/K193647.md) | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | Jul 29, 2020 | SESE |

## Top Applicants

- Cordis Corp. — 28 clearances
- Boston Scientific Corp — 19 clearances
- C.R. Bard, Inc. — 16 clearances
- Scimed Life Systems, Inc. — 16 clearances
- AngioDynamics, Inc. — 11 clearances

---

**Source:** [https://fda.innolitics.com/productcode/DQO](https://fda.innolitics.com/productcode/DQO)

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