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 |
|---|---|---|---|
| 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 |
| K180054 | Royal Flush Plus High-Flow Catheter | Cook Incorporated | 2018-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450787663 | Impress® | Merit Medical Systems, Inc. | 2026-06-08 |
| 00885403522270 | Swan-Ganz | Becton, Dickinson And Company | 2026-05-30 |
| 00885403522386 | Swan-Ganz | Becton, Dickinson And Company | 2026-05-30 |
| 00884450766958 | Performa® | Merit Medical Systems, Inc. | 2026-05-28 |
| 07613327313956 | Trevo Trak 21 | Stryker Corporation | 2020-04-17 |
| 08714729214083 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213208 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213369 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213666 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213741 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213888 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213918 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729214007 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213178 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729214120 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729214168 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729214243 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729214342 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213192 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213185 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729213161 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729200291 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729188865 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729152989 | Impulse™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 07613327313987 | DAC 044 | Stryker Corporation | 2016-09-21 |
| 07613327313963 | DAC 070 | Stryker Corporation | 2016-09-21 |
| 07613327313925 | DAC 044 | Stryker Corporation | 2016-09-21 |
| 07613327313918 | DAC 044 | Stryker Corporation | 2016-09-21 |
| 07613327313895 | DAC 038 | Stryker Corporation | 2016-09-21 |
| 00847536003569 | ReverseTM | Reverse Medical Corporation | 2016-08-12 |