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)
FDA 510(k) K252638 · Acist Medical Systems, Inc.
510(k) numberK252638
Submission
- Device name
- 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)
- Applicant
- Acist Medical Systems, Inc.
Eden Prairie, MN, US - Received
- August 20, 2025
- Decision date
- May 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXT – Injector And Syringe, Angiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code DXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional | Fortis Biosolutions Company Limited | 05/14/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional | Shenzhen Maiwei Biotech Co., Ltd. | 04/16/2026SE |
| K251788 | Extension tubeDXT · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 03/05/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | Bayer Medical Care, Inc. | 02/13/2026SE |
| K244038 | High Pressure TubingDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 09/05/2025SE |
| K242143 | Angiography InjectorDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 12/23/2024SE |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)DXT · Traditional | Nemoto Kyorindo Co., Ltd. | 08/27/2024SE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/22/2024SE |
| K230668 | Disposable High-pressure Extension LinesDXT · Traditional | Precision Medical Plastics , Ltd. | 06/14/2024SE |
More from Precision Medical Plastics , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery SystemIZQ · Traditional | 08/03/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | 05/13/2026SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | 07/17/2024SE |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDXT · Special | 12/17/2020SE |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ · Special | 03/20/2020SE |
| K190473 | ACIST RXi System and Navvus II CatheterOBI · Traditional | 09/13/2019SE |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…DXT · Traditional | 07/18/2019SE |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Traditional | 06/27/2019SE |
| K171646 | ACISTCVi® Contrast Delivery SystemDXT · Traditional | 02/16/2018SE |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Special | 10/23/2017SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K252638) received a 510(k) decision of Substantially Equivalent on May 13, 2026, 266 days after the submission was received.
What is the product code of K252638?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.