Product code DQO
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-06-26 |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502... | Bioptimal International Pte. , Ltd. | 2026-05-28 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290017268392 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268835 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268828 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268811 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268804 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268408 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268385 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268361 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268330 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268323 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268309 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268316 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2021-07-22 |
| 07290017268019 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268026 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268033 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268040 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268583 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268576 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268569 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268552 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268545 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268538 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268521 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268514 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268507 | Drakon | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268057 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268002 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268064 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268071 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |
| 07290017268088 | SeQure | ACCURATE MEDICAL THERAPEUTICS LTD | 2018-08-10 |