DQO
- Product code
- DQO
- Device name
- Catheter, Intravascular, Diagnostic
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 501 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261455 | 2026-06-26 | Spectrum Vascular | Arterial Pressure Monitoring Set/Tray | |
| K252702 | 2026-05-28 | Bioptimal International Pte. , Ltd. | Bioptimal Pulmonary Artery Monitoring Catheter (TD25… | |
| K254278 | 2026-03-25 | Spectrum Vascular | Arterial Pressure Monitoring Set/Tray | |
| K250751 | 2025-07-17 | Terumo Corporation | DualView Catheter | |
| K242966 | 2025-01-31 | Gentuity, LLC | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® M… | |
| K242420 | 2024-11-12 | Phenox, Ltd. | pNOVUS 21 Microcatheter | |
| K233268 | 2024-05-22 | Merit Medical Systems, Inc. | Impress Angiographic Catheter | |
| K233975 | 2024-04-02 | Imperative Care, Inc. | Zoom 6F Insert Catheters | |
| K232536 | 2024-02-23 | Embolx, Inc. | Soldier Microcatheter | |
| K232573 | 2023-11-21 | Cordis US Corp | INFINITI Ambi Angiographic Catheter |
Official FDA classification page: DQO
Classification and pathway per current FDA publications. Data from openFDA (CC0).