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/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/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 499) Showing 20 most recent of 499 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254278](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K254278.md) | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Mar 25, 2026 | SESE | | [K250751](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K250751.md) | DualView Catheter | Terumo Corporation | Jul 17, 2025 | SESE | | [K242966](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K242966.md) | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | Jan 31, 2025 | SESE | | [K242420](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K242420.md) | pNOVUS 21 Microcatheter | Phenox, Ltd. | Nov 12, 2024 | SESE | | [K233268](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K233268.md) | Impress Angiographic Catheter | Merit Medical Systems, Inc. | May 22, 2024 | SESE | | [K233975](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K233975.md) | Zoom 6F Insert Catheters | Imperative Care, Inc. | Apr 2, 2024 | SESE | | [K232536](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K232536.md) | Soldier Microcatheter | Embolx, Inc. | Feb 23, 2024 | SESE | | [K232573](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K232573.md) | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp | Nov 21, 2023 | SESE | | [K230620](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K230620.md) | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | Aug 8, 2023 | SESE | | [K231293](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K231293.md) | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics | Jun 1, 2023 | SESE | | [K230411](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K230411.md) | Dragonfly OpStar™ Imaging Catheter | ABBOTT MEDICAL | Apr 14, 2023 | SESE | | [K221279](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K221279.md) | pNOVUS 21 Microcatheter | Phenox, Ltd. | Nov 28, 2022 | SESE | | [K213666](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K213666.md) | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | Oct 6, 2022 | SESE | | [K221470](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K221470.md) | Langston dual lumen catheter | Vascular Solutions, LLC | Jun 17, 2022 | SESE | | [K212977](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K212977.md) | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | Feb 17, 2022 | SESE | | [K211078](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K211078.md) | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | Dec 21, 2021 | SESE | | [K203487](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K203487.md) | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | Dec 11, 2020 | SESE | | [K202797](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K202797.md) | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | Oct 23, 2020 | SESE | | [K193647](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K193647.md) | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | Jul 29, 2020 | SESE | | [K192267](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K192267.md) | ILUMIEN System with AptiVue Software version D.3 | ABBOTT MEDICAL | Dec 17, 2019 | 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/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com