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 | June 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 | March 25, 2026 |
| K250751 | terumo corporation | DualView Catheter | July 17, 2025 |
| K242966 | gentuity | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | January 31, 2025 |
| K242420 | phenox | pNOVUS 21 Microcatheter | November 12, 2024 |
| K233268 | merit medical systems | Impress Angiographic Catheter | May 22, 2024 |
| K233975 | imperative care | Zoom 6F Insert Catheters | April 2, 2024 |
| K232536 | embolx | Soldier Microcatheter | February 23, 2024 |
| K232573 | cordis us | INFINITI Ambi Angiographic Catheter | November 21, 2023 |
| K230620 | gentuity | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | August 8, 2023 |
| K231293 | accurate medical therapeutics | Drakon and Sequre® Microcatheters | June 1, 2023 |
| K230411 | abbott medical | Dragonfly OpStar Imaging Catheter | April 14, 2023 |
| K221279 | phenox | pNOVUS 21 Microcatheter | November 28, 2022 |
| K213666 | pfm medical | NuCath Wedge Pressure Catheter | October 6, 2022 |
| K221470 | vascular solutions | Langston dual lumen catheter | June 17, 2022 |
| K212977 | cordis corporation | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | February 17, 2022 |
| K211078 | terumo clinical supply co | Progreat Lambda | December 21, 2021 |
| K203487 | accurate medical therapeutics | Drakon and Sequre Microcatheters | December 11, 2020 |
| K202797 | accurate medical therapeutics | Drakon and Sequre Microcatheters | October 23, 2020 |