Sterile High-pressure Angiographic Syringes for single-use
FDA 510(k) K201395 · Youwo (Guangzhou) Medical Device Co., Ltd.
510(k) numberK201395
Submission
- Device name
- Sterile High-pressure Angiographic Syringes for single-use
- Applicant
- Youwo (Guangzhou) Medical Device Co., Ltd.
Guangzhou, CN - Received
- May 27, 2020
- Decision date
- October 28, 2020
- 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 |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…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 |
Questions and answers
When was Sterile High-pressure Angiographic Syringes for single-use cleared by the FDA?
Sterile High-pressure Angiographic Syringes for single-use (K201395) received a 510(k) decision of Substantially Equivalent on October 28, 2020, 154 days after the submission was received.
What is the product code of K201395?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.