Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1650](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1650) → DXT — Injector And Syringe, Angiographic # DXT · Injector And Syringe, Angiographic _Cardiovascular · 21 CFR 870.1650 · Class 2_ **Canonical URL:** https://fda.innolitics.com/productcode/DXT ## Overview - **Product Code:** DXT - **Device Name:** Injector And Syringe, Angiographic - **Regulation:** [21 CFR 870.1650](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1650) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](/device/K252652.md) | 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](/device/K252653.md) | 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](/device/K252638.md) | 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](/device/K253048.md) | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | Apr 16, 2026 | SESE | | [K251788](/device/K251788.md) | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | Mar 5, 2026 | SESE | | [K252891](/device/K252891.md) | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | Feb 13, 2026 | SESE | | [K244038](/device/K244038.md) | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | Sep 5, 2025 | SESE | | [K242143](/device/K242143.md) | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | Dec 23, 2024 | SESE | | [K242212](/device/K242212.md) | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | Aug 27, 2024 | SESE | | [K241109](/device/K241109.md) | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. | Aug 22, 2024 | SESE | | [K230668](/device/K230668.md) | Disposable High-pressure Extension Lines | Precision Medical Plastics , Ltd. | Jun 14, 2024 | SESE | | [K232388](/device/K232388.md) | High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd | Nov 21, 2023 | SESE | | [K211564](/device/K211564.md) | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | Oct 19, 2021 | SESE | | [K203004](/device/K203004.md) | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Acist Medical Systems, Inc. | Dec 17, 2020 | SESE | | [K201395](/device/K201395.md) | Sterile High-pressure Angiographic Syringes for single-use | Youwo (Guangzhou) Medical Device Co., Ltd. | Oct 28, 2020 | SESE | | [K192657](/device/K192657.md) | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | Aug 7, 2020 | SESE | | [K192370](/device/K192370.md) | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | Bayer Medical Care, Inc. | Dec 13, 2019 | SESE | | [K193028](/device/K193028.md) | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | Dec 5, 2019 | SESE | | [K190102](/device/K190102.md) | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System | Osprey Medical, Inc. | Oct 17, 2019 | SESE | | [K191060](/device/K191060.md) | 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 --- **Source:** [https://fda.innolitics.com/productcode/DXT](https://fda.innolitics.com/productcode/DXT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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