DXT · Injector And Syringe, Angiographic
Cardiovascular · 21 CFR 870.1650 · Class 2
Overview
| Product Code | DXT |
|---|---|
| Device Name | Injector And Syringe, Angiographic |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 210)
Showing 20 most recent of 210 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | Fortis Biosolutions Company Limited | May 14, 2026 | SESE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | Acist Medical Systems, Inc. | May 13, 2026 | SESE |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | Acist Medical Systems, Inc. | May 13, 2026 | SESE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | Apr 16, 2026 | SESE |
| K251788 | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | Mar 5, 2026 | SESE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | Feb 13, 2026 | SESE |
| K244038 | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | Sep 5, 2025 | SESE |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | Dec 23, 2024 | SESE |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | Aug 27, 2024 | SESE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. | Aug 22, 2024 | SESE |
| K230668 | Disposable High-pressure Extension Lines | Precision Medical Plastics , Ltd. | Jun 14, 2024 | SESE |
| K232388 | High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd | Nov 21, 2023 | SESE |
| K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | Oct 19, 2021 | SESE |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | Dec 17, 2020 | SESE |
| K201395 | Sterile High-pressure Angiographic Syringes for single-use | Youwo (Guangzhou) Medical Device Co., Ltd. | Oct 28, 2020 | SESE |
| K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | Aug 7, 2020 | SESE |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | Bayer Medical Care, Inc. | Dec 13, 2019 | SESE |
| K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | Dec 5, 2019 | SESE |
| K190102 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System | Osprey Medical, Inc. | Oct 17, 2019 | SESE |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | Acist Medical Systems, Inc. | Jul 18, 2019 | SESE |
Top Applicants
- Medrad, Inc. — 32 clearances
- Osprey Medical, Inc. — 14 clearances
- Coeur, Inc. — 10 clearances
- Acist Medical Systems, Inc. — 8 clearances
- Bayer Medical Care, Inc. — 7 clearances
