DQO · Catheter, Intravascular, Diagnostic
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | DQO |
|---|---|
| Device Name | Catheter, Intravascular, Diagnostic |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | 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 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | Mar 25, 2026 | SESE |
| K250751 | DualView Catheter | Terumo Corporation | Jul 17, 2025 | SESE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | Jan 31, 2025 | SESE |
| K242420 | pNOVUS 21 Microcatheter | Phenox, Ltd. | Nov 12, 2024 | SESE |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | May 22, 2024 | SESE |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | Apr 2, 2024 | SESE |
| K232536 | Soldier Microcatheter | Embolx, Inc. | Feb 23, 2024 | SESE |
| K232573 | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp | Nov 21, 2023 | SESE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | Aug 8, 2023 | SESE |
| K231293 | Drakon™ and Sequre® Microcatheters | Accurate Medical Therapeutics | Jun 1, 2023 | SESE |
| K230411 | Dragonfly OpStar™ Imaging Catheter | ABBOTT MEDICAL | Apr 14, 2023 | SESE |
| K221279 | pNOVUS 21 Microcatheter | Phenox, Ltd. | Nov 28, 2022 | SESE |
| K213666 | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | Oct 6, 2022 | SESE |
| K221470 | Langston dual lumen catheter | Vascular Solutions, LLC | Jun 17, 2022 | SESE |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | Feb 17, 2022 | SESE |
| K211078 | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | Dec 21, 2021 | SESE |
| K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | Dec 11, 2020 | SESE |
| K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | Oct 23, 2020 | SESE |
| K193647 | 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
