DXT
- Product code
- DXT
- Device name
- Injector And Syringe, Angiographic
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1650
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 12
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 210 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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 |
Official FDA classification page: DXT
Classification and pathway per current FDA publications. Data from openFDA (CC0).