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 207)
Showing 20 most recent of 207 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 |
| K183267 | DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | Dec 20, 2018 | SESE |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | Bayer Medical Care, Inc. | Nov 1, 2018 | SESE |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | Bayer Medical Care, Inc. | Nov 1, 2018 | SESE |
Top Applicants
- Medrad, Inc. — 32 clearances
- Osprey Medical, Inc. — 14 clearances
- Coeur, Inc. — 10 clearances
- Vertex Medical Corp. — 7 clearances
- Nemoto Kyorindo Co., Ltd. — 7 clearances
