Product code DQO
Current FDA Classification
- Device name
- Catheter, Intravascular, Diagnostic
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1200
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-03-25 |
| K250751 | DualView Catheter | Terumo Corporation | 2025-07-17 |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | 2025-01-31 |
| K242420 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2024-11-12 |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2024-05-22 |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | 2024-04-02 |
| K232536 | Soldier Microcatheter | Embolx, Inc. | 2024-02-23 |
| K232573 | INFINITI Ambi Angiographic Catheter | Cordis US Corp | 2023-11-21 |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | 2023-08-08 |
| K231293 | Drakon and Sequre® Microcatheters | Accurate Medical Therapeutics | 2023-06-01 |
| K230411 | Dragonfly OpStar Imaging Catheter | ABBOTT MEDICAL | 2023-04-14 |
| K221279 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2022-11-28 |
| K213666 | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | 2022-10-06 |
| K221470 | Langston dual lumen catheter | Vascular Solutions, LLC | 2022-06-17 |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | 2022-02-17 |
| K211078 | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | 2021-12-21 |
| K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020-12-11 |
| K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020-10-23 |
| K193647 | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-07-29 |
| K192267 | ILUMIEN System with AptiVue Software version D.3 | ABBOTT MEDICAL | 2019-12-17 |
| K192122 | Trevo Trak 21 Microcatheter | Stryker | 2019-11-22 |
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 | ABBOTT MEDICAL | 2019-11-08 |
| K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019-08-22 |
| K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2019-07-16 |
| K181722 | Polyethylene Catheter | Cook Incorporated | 2019-03-22 |
| K180846 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018-12-19 |
| K180792 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018-11-30 |
| K180286 | Polyethylene Catheter | Cook Incorporated | 2018-10-26 |
| K180054 | Royal Flush Plus High-Flow Catheter | Cook Incorporated | 2018-10-05 |
| K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters | Cordis, A Cardinal Health Company | 2018-08-08 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884450788407 | Impress® | Merit Medical Systems, Inc. | 2026-03-21 |
| 10884450787080 | Impress® | Merit Medical Systems, Inc. | 2026-03-19 |
| 50690103218607 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2026-03-16 |
| 10884450710729 | Impress® | Merit Medical Systems, Inc. | 2026-03-11 |
| 20841156111486 | LANGSTON | TELEFLEX INCORPORATED | 2026-03-11 |
| 10884450787103 | Impress® | Merit Medical Systems, Inc. | 2026-03-03 |
| 10884450787455 | Impress® | Merit Medical Systems, Inc. | 2026-03-03 |
| 10884450788070 | Impress® | Merit Medical Systems, Inc. | 2026-02-19 |
| 10884450787653 | Impress® | Merit Medical Systems, Inc. | 2026-02-14 |
| 10884450852849 | Impress® | Merit Medical Systems, Inc. | 2026-02-14 |
| 50690103000417 | SWAN-GANZ | Edwards Lifesciences LLC | 2026-01-30 |
| 00884450722329 | Impress® | Merit Medical Systems, Inc. | 2026-01-28 |
| 10885672003323 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003316 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003309 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003293 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003286 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003262 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003255 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003248 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003231 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672003057 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672002975 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672002012 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672002005 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672001992 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672001985 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672001978 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672001961 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |
| 10885672001954 | Angios Classic Angiographic Catheter | Oscor Inc. | 2017-11-16 |