DQO — Catheter, Intravascular, Diagnostic Class II
FDA product code DQO covers "Catheter, Intravascular, Diagnostic", a Class II medical device regulated under 21 CFR 870.1200. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DQO
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261455 | Spectrum Vascular | Arterial Pressure Monitoring Set/Tray | Jun 26, 2026 |
| K252702 | Bioptimal International Pte. | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, | May 28, 2026 |
| K254278 | Spectrum Vascular | Arterial Pressure Monitoring Set/Tray | Mar 25, 2026 |
| K250751 | Terumo Corporation | DualView Catheter | Jul 17, 2025 |
| K242966 | Gentuity | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Jan 31, 2025 |
| K242420 | Phenox | pNOVUS 21 Microcatheter | Nov 12, 2024 |
| K233268 | Merit Medical Systems | Impress Angiographic Catheter | May 22, 2024 |
| K233975 | Imperative Care | Zoom 6F Insert Catheters | Apr 2, 2024 |
| K232536 | Embolx | Soldier Microcatheter | Feb 23, 2024 |
| K232573 | Cordis Us | INFINITI Ambi Angiographic Catheter | Nov 21, 2023 |
| K230620 | Gentuity | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Aug 8, 2023 |
| K231293 | Accurate Medical Therapeutics | Drakon and Sequre® Microcatheters | Jun 1, 2023 |
| K230411 | Abbott Medical | Dragonfly OpStar Imaging Catheter | Apr 14, 2023 |
| K221279 | Phenox | pNOVUS 21 Microcatheter | Nov 28, 2022 |
| K213666 | Pfm Medical | NuCath Wedge Pressure Catheter | Oct 6, 2022 |
| K221470 | Vascular Solutions | Langston dual lumen catheter | Jun 17, 2022 |
| K212977 | Cordis Corporation | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Feb 17, 2022 |
| K211078 | Terumo Clinical Supply Co | Progreat Lambda | Dec 21, 2021 |
| K203487 | Accurate Medical Therapeutics | Drakon and Sequre Microcatheters | Dec 11, 2020 |
| K202797 | Accurate Medical Therapeutics | Drakon and Sequre Microcatheters | Oct 23, 2020 |