510(k) K201929
- Device
- KDL Angiography Catheter
- Applicant
- Shanghai Kindly Medical Instruments Co., Ltd.
- 510(k) number
- K201929
- Product code
- DQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-14
- Date received
- 2020-07-10
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Diagnostic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code DQO #
| 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 |
Legacy Summary#
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FDA Review#
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