DXT
- 产品代码
- DXT
- 器械名称
- Injector And Syringe, Angiographic
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.1650
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 210 件
该代码近三年的 510(k)（12 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252652 | 2026-05-14 | Fortis Biosolutions Company Limited | Disposable Syringes with Accessories for Power Injec | |
| K252653 | 2026-05-13 | Acist Medical Systems, Inc. | ACIST Pro Diagnostic System (019304); Processing Uni | |
| K252638 | 2026-05-13 | Acist Medical Systems, Inc. | VeraPro S100 Multi-Use Syringe (018808); VeraPro S10 | |
| K253048 | 2026-04-16 | Shenzhen Maiwei Biotech Co., Ltd. | High Pressure Syringe; Pressure Connecting Tube; Qui | FDA |
| K251788 | 2026-03-05 | Zhuhai DR Medical Instruments Co., Ltd | Extension tube | |
| K252891 | 2026-02-13 | Bayer Medical Care, Inc. | MEDRAD MRXperion MR Injection System and MR Injectio | |
| K244038 | 2025-09-05 | Shandong Int Medical Instruments Co., | High Pressure Tubing | FDA |
| K242143 | 2024-12-23 | Shandong Int Medical Instruments Co., | Angiography Injector | |
| K242212 | 2024-08-27 | Nemoto Kyorindo Co., Ltd. | Disposable Syringe (Kit); Nemoto Disposable Syringe | |
| K241109 | 2024-08-22 | Shenzhen Boon Medical Supply Co., Ltd. | Single-use Sterile High-pressure Angiographic Syring | |
| K230668 | 2024-06-14 | Precision Medical Plastics , Ltd. | Disposable High-pressure Extension Lines | — |
| K232388 | 2023-11-21 | Ningbo Dizegens Medical Science Co.,Lt | High Pressure Tubing |
FDA 官方分类页： DXT
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。